{
"NDC": [
{
"NDCCode": "42291-846-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42291-846-60) ",
"NDC11Code": "42291-0846-60",
"ProductNDC": "42291-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trospium Chloride",
"NonProprietaryName": "Trospium Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091513",
"LabelerName": "AvKARE",
"SubstanceName": "TROSPIUM CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20161006",
"SamplePackage": "N"
},
{
"NDCCode": "13411-846-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (13411-846-60) ",
"NDC11Code": "13411-0846-60",
"ProductNDC": "13411-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "St. Paul Brands Glucotrojan",
"NonProprietaryName": "Mangifera Indica Leaf Extract,stem Banana Extract,white Mulberry (morus Alba) Leaf Extract",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240314",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals",
"SubstanceName": "BANANA; MANGIFERA INDICA LEAF; MORUS ALBA LEAF",
"StrengthNumber": "250; 250; 250",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fruit Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240314",
"SamplePackage": "N"
},
{
"NDCCode": "16590-846-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (16590-846-60)",
"NDC11Code": "16590-0846-60",
"ProductNDC": "16590-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Savella",
"NonProprietaryName": "Milnacipran Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090417",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022256",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "MILNACIPRAN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Savella is indicated for the management of fibromyalgia. Savella is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].",
"Description": "Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor; it inhibits norepinephrine uptake with greater potency than serotonin. It is a racemic mixture with the chemical name: (±)-[1R(S),2S(R)]-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride. The structural formula is. Milnacipran hydrochloride is a white to off-white crystalline powder with a melting point of 179°C. It is freely soluble in water, methanol, ethanol, chloroform, and methylene chloride and sparingly soluble in diethyl ether. It has an empirical formula of C15H23ClN2O and a molecular weight of 282.8 g/mol. Savella is available for oral administration as film-coated tablets containing 12.5 mg, 25 mg, 50 mg, and 100 mg milnacipran hydrochloride. Each tablet also contains dibasic calcium phosphate, povidone, carboxymethylcellulose calcium, colloidal silicon dioxide, magnesium stearate, and talc as inactive ingredients. Additionally, the following inactive ingredients are also present as components of the film coat. 12.5 mg. FD&C Red #40 Aluminum Lake dye, hypromellose, polyethylene glycol, titanium dioxide. 25 mg. Hypromellose, polyethylene glycol, titanium dioxide. 50 mg. FD&C Blue #1, Blue #2, and Yellow #5 Aluminum Lake dyes; hypromellose; polyethylene glycol; titanium dioxide. 100 mg. FD&C Blue #1 Aluminum Lake dye, hypromellose, polyethylene glycol, titanium dioxide."
},
{
"NDCCode": "31722-846-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (31722-846-60) ",
"NDC11Code": "31722-0846-60",
"ProductNDC": "31722-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Milnacipran Hydrochloride",
"NonProprietaryName": "Milnacipran Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205147",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "MILNACIPRAN HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260319",
"SamplePackage": "N",
"IndicationAndUsage": "Milnacipran hydrochloride tablets are indicated for the management of fibromyalgia. Milnacipran hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)].",
"Description": "Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor; it inhibits norepinephrine uptake with greater potency than serotonin. The chemical name: (1R,2S)-rel-2- (Amino-methyl)-N,N-diethyl-1-phenylcyclo propane carboxamide hydrochloride. The structural formula is. Milnacipran hydrochloride is a white to off-white powder with a melting point of 179°C. It is freely soluble in water, methanol and in dimethysulphoxide, soluble in dimethyl formamide. It has an empirical formula of C 15H 22N 2O.HCl and a molecular weight of 282.81 g/mol. Milnacipran hydrochloride tablets are available for oral administration as film-coated tablets containing 12.5 mg, 25 mg, 50 mg, and 100 mg milnacipran hydrochloride. Each tablet also contains carboxymethylcellulose calcium, colloidal silicon dioxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc and titanium dioxide as inactive ingredients. Additionally, the 12.5 mg tablets contain FD & C Blue #2/Indigo Carmine Aluminum Lake and the 100 mg tablets contain FD&C Red #40 Allura Red AC-Aluminum Lake."
},
{
"NDCCode": "35356-846-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (35356-846-60)",
"NDC11Code": "35356-0846-60",
"ProductNDC": "35356-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076639",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-10-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "45865-846-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (45865-846-60) ",
"NDC11Code": "45865-0846-60",
"ProductNDC": "45865-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071009",
"EndMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077802",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "49999-846-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (49999-846-60)",
"NDC11Code": "49999-0846-60",
"ProductNDC": "49999-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfateer",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076438",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-04-03",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "52959-846-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 CONTAINER (52959-846-60) ",
"NDC11Code": "52959-0846-60",
"ProductNDC": "52959-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078048",
"LabelerName": "H. J. Harkins Company Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20H21N HCl and a molecular weight of 311.9. It has a melting point of 217°C and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Each 5 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 5 mg Cyclobenzaprine hydrochloride. Each 10 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 10 mg Cyclobenzaprine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, carnauba wax, titanium dioxide, polyethylene glycol, and iron oxide yellow. In addition, 5 mg tablets also contain polyvinyl alcohol, talc, lecithin, and FD&C yellow # 6 / sunset yellow FCF aluminum lake. In addition, 10 mg tablets also contain D&C yellow # 10 aluminum lake, FD&C yellow # 6 aluminum lake and hypromellose."
},
{
"NDCCode": "59779-846-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (59779-846-06) > 60 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "59779-0846-06",
"ProductNDC": "59779-846",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diarrhea",
"NonProprietaryName": "Cinchona Officinalis, Bryonia, Chamomilla, Colocynthis, Ipecacuanha, Belladonna",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140429",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "CVS PHARMACY",
"SubstanceName": "CINCHONA OFFICINALIS BARK; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; ATROPA BELLADONNA",
"StrengthNumber": "8; 8; 8; 8; 8; 8",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of diarrhea. - diarrhea. - painful cramps. - nausea."
},
{
"NDCCode": "60429-846-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (60429-846-60) ",
"NDC11Code": "60429-0846-60",
"ProductNDC": "60429-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valganciclovir",
"NonProprietaryName": "Valganciclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203511",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "VALGANCICLOVIR HYDROCHLORIDE",
"StrengthNumber": "450",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181102",
"SamplePackage": "N",
"Description": "Valganciclovir tablets USP contains valganciclovir hydrochloride USP, a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir hydrochloride USP is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir hydrochloride USP (corresponding to 450 mg of valganciclovir), and the inactive ingredients crospovidone, magnesium stearate, microcrystalline cellulose and povidone. The film-coat applied to the tablets contains hypromellose, iron oxide red, polyethylene glycol, polysorbate and titanium dioxide. Valganciclovir hydrochloride USP is a white to almost white powder with a molecular formula of C 14H 22N 6O 5·HCl and a molecular weight of 390.71. The chemical name for valganciclovir hydrochloride USP is L-Valine, 2[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir hydrochloride USP is a polar hydrophilic compound with a saturation solubility of 6029 mg/mL in water at 25°C and an n-octanol/water partition coefficient of 0.00701 at pH 5.1. The pKa for valganciclovir hydrochloride USP is 7.2. The chemical structure of valganciclovir hydrochloride USP is. All doses in this insert are specified in terms of valganciclovir."
},
{
"NDCCode": "60760-846-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (60760-846-60) ",
"NDC11Code": "60760-0846-60",
"ProductNDC": "60760-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260318",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206943",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260318",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin capsules, USP are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: Pregelatinized Maize starch, talc, gelatin, titanium dioxide, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (300 mg and 400 mg only), black iron oxide (300 mg and 400 mg only). Ingredients of Imprinting Ink (Black SW-9049) are Black Iron Oxide NF (E 172), Butyl Alcohol NF, Dehydrated Alcohol USP, Isopropyl Alcohol USP, Potassium Hydroxide NF, Propylene Glycol USP, Shellac NF, and Strong Ammonia Solution NF."
},
{
"NDCCode": "63187-846-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (63187-846-60) ",
"NDC11Code": "63187-0846-60",
"ProductNDC": "63187-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071136",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170501",
"SamplePackage": "N",
"IndicationAndUsage": "Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1."
},
{
"NDCCode": "65841-846-14",
"PackageDescription": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-846-14) ",
"NDC11Code": "65841-0846-14",
"ProductNDC": "65841-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20241024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078877",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241024",
"SamplePackage": "N"
},
{
"NDCCode": "71205-846-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (71205-846-60) ",
"NDC11Code": "71205-0846-60",
"ProductNDC": "71205-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "16.2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230213",
"SamplePackage": "N",
"IndicationAndUsage": "1. Sedative 2. 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. C12H12N2O3 M.W. = 232.24 Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "71610-846-53",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71610-846-53) ",
"NDC11Code": "71610-0846-53",
"ProductNDC": "71610-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216751",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240717",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .",
"Description": "Mirtazapine tablets, USP contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the empirical formula of C 17H 19N 3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture:. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, and titanium dioxide. The 7.5 mg tablets also contain sunset yellow FCF lake and Allura red AC lake. The 15 mg tablets also contain iron oxide yellow, quinoline yellow lake and sunset yellow FCF lake. The 30 mg tablets also contain ferric oxide yellow, ferric oxide red and ferrosoferric oxide/iron oxide black. FDA approved dissolution method differs from the USP dissolution testing."
},
{
"NDCCode": "76420-846-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (76420-846-60) ",
"NDC11Code": "76420-0846-60",
"ProductNDC": "76420-846",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202413",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240908",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets, USP contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77°C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, soidum starch glycoate, stearic acid, talc, titanium dioxide."
},
{
"NDCCode": "42291-033-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (42291-033-60) ",
"NDC11Code": "42291-0033-60",
"ProductNDC": "42291-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213879",
"LabelerName": "AvKARE",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241127",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days ( 1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4) .",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine,N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C 35H 45N 7O 8S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is:. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, soluble in ethanol, and practically insoluble in ethyl acetate. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, magnesium stearate, talc, tartaric acid pellets. The capsule shell is composed of hypromellose, titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac."
},
{
"NDCCode": "42291-034-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (42291-034-60) ",
"NDC11Code": "42291-0034-60",
"ProductNDC": "42291-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213879",
"LabelerName": "AvKARE",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241127",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days ( 1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4) .",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine,N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C 35H 45N 7O 8S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is:. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, soluble in ethanol, and practically insoluble in ethyl acetate. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, magnesium stearate, talc, tartaric acid pellets. The capsule shell is composed of hypromellose, titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac."
},
{
"NDCCode": "42291-043-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (42291-043-60) ",
"NDC11Code": "42291-0043-60",
"ProductNDC": "42291-043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefdinir",
"NonProprietaryName": "Cefdinir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065368",
"LabelerName": "AvKARE",
"SubstanceName": "CEFDINIR",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240613",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
"Description": "Cefdinir Capsules USP contain the active ingredient cefdinir, USP an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is (6 R,7 R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir,USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7.0 phosphate buffer. Cefdinir has the structural formula shown below:. C 14H 13N 5O 5S 2M.W. 395.41. Cefdinir Capsules USP contain 300 mg cefdinir, USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C green #3, FD&C red #40, FD&C red #40 aluminum lake, gelatin, iron oxide black, magnesium stearate, polyoxyl 40 stearate, propylene glycol, shellac glaze, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "42291-073-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42291-073-60) ",
"NDC11Code": "42291-0073-60",
"ProductNDC": "42291-073",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208327",
"LabelerName": "AvKARE",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210429",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC) .",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. ."
},
{
"NDCCode": "42291-076-60",
"PackageDescription": "1 TUBE in 1 CARTON (42291-076-60) / 60 g in 1 TUBE",
"NDC11Code": "42291-0076-60",
"ProductNDC": "42291-076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211256",
"LabelerName": "AvKARE",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200618",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol propionate cream, USP 0.05% contains the active compound clobetasol propionate, USP, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate, USP, is pregna-1, 4-diene-3, 20-dione, 21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (11ß,16ß) and it has the following structural formula. Clobetasol propionate, USP has the empirical formula C 25H 32CIFO 5 and a molecular weight of 466.97. It is a white to almost white crystalline powder insoluble in water. Clobetasol propionate cream, USP, contains clobetasol propionate 0.5 mg/g in a cream base of anhydrous citric acid, cetyl alcohol, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide pellets may be used to adjust pH."
},
{
"NDCCode": "42291-077-60",
"PackageDescription": "1 TUBE in 1 CARTON (42291-077-60) / 60 g in 1 TUBE",
"NDC11Code": "42291-0077-60",
"ProductNDC": "42291-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209701",
"LabelerName": "AvKARE",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200618",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol Propionate Ointment USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol Propionate Ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C 25H 32ClFO 5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water; slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "42291-111-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-111-60)",
"NDC11Code": "42291-0111-60",
"ProductNDC": "42291-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078387",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2015-04-24"
},
{
"NDCCode": "42291-112-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-112-60)",
"NDC11Code": "42291-0112-60",
"ProductNDC": "42291-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078387",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2015-04-24"
},
{
"NDCCode": "42291-113-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-113-60)",
"NDC11Code": "42291-0113-60",
"ProductNDC": "42291-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078387",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2015-04-24"
},
{
"NDCCode": "42291-116-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (42291-116-60) ",
"NDC11Code": "42291-0116-60",
"ProductNDC": "42291-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aspirin And Extended-release Dipyridamole",
"NonProprietaryName": "Aspirin And Extended-release Dipyridamole",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206392",
"LabelerName": "AvKARE",
"SubstanceName": "ASPIRIN; DIPYRIDAMOLE",
"StrengthNumber": "25; 200",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170427",
"SamplePackage": "N",
"IndicationAndUsage": "Aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.",
"Description": "Aspirin and extended-release dipyridamole is a combination antiplatelet agent intended for oral administration. Each hard gelatin capsule contains 200 mg dipyridamole, USP in an extended-release form and 25 mg aspirin USP, as an immediate-release sugar-coated tablet. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, hypromellose phthalate, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, simethicone, stearic acid, sucrose, talc, tartaric acid, triethyl citrate and triacetin. Each capsule shell contains D&C Yellow #10, gelatin, iron oxide red, iron oxide yellow, purified water, sodium lauryl sulfate and titanium dioxide. The imprinting inks contain butyl alcohol, D&C Yellow #10, dehydrated alcohol, FD&C Red #40, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dipyridamole, USP. Dipyridamole, USP is an antiplatelet agent chemically described as 2,2',2'',2'''-[(4,8-Dipiperidinopyrimido[5,4- d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula:. Dipyridamole, USP is an odorless yellow crystalline substance, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and is practically insoluble in water. Aspirin, USP. The antiplatelet agent aspirin, USP (acetylsalicylic acid) is chemically known as benzoic acid, 2- (acetyloxy)-, and has the following structural formula:. Aspirin, USP is an odorless white needle-like crystalline or powdery substance. When exposed to moisture, aspirin hydrolyzes into salicylic and acetic acids, and gives off a vinegary odor. It is highly lipid soluble and slightly soluble in water."
},
{
"NDCCode": "42291-148-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-148-60) ",
"NDC11Code": "42291-0148-60",
"ProductNDC": "42291-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202984",
"LabelerName": "AvKARE",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20231231",
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{
"NDCCode": "42291-154-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42291-154-60) ",
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"ProductNDC": "42291-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"LabelerName": "AvKARE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
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"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine hydrochloride tablets USP, for oral administration, are available in the following strengths: 5 mg, 7.5 mg and 10 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg tablet contain FD&C yellow # 6, and both the 5 mg and 10 mg tablets contain iron oxide yellow."
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{
"NDCCode": "42291-166-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42291-166-60) ",
"NDC11Code": "42291-0166-60",
"ProductNDC": "42291-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Capecitabine",
"NonProprietaryName": "Capecitabine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204741",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "CAPECITABINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180511",
"SamplePackage": "N"
},
{
"NDCCode": "42291-190-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42291-190-60) ",
"NDC11Code": "42291-0190-60",
"ProductNDC": "42291-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Capecitabine",
"NonProprietaryName": "Capecitabine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091649",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "CAPECITABINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150320",
"SamplePackage": "N"
}
]
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trospium Chloride</ProprietaryName>
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<LastUpdate>2021-07-14</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<PackageDescription>60 CAPSULE in 1 BOTTLE (13411-846-60) </PackageDescription>
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<ProductNDC>13411-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>St. Paul Brands Glucotrojan</ProprietaryName>
<NonProprietaryName>Mangifera Indica Leaf Extract,stem Banana Extract,white Mulberry (morus Alba) Leaf Extract</NonProprietaryName>
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<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals</LabelerName>
<SubstanceName>BANANA; MANGIFERA INDICA LEAF; MORUS ALBA LEAF</SubstanceName>
<StrengthNumber>250; 250; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fruit Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
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<LastUpdate>2024-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<ProductNDC>16590-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Savella</ProprietaryName>
<NonProprietaryName>Milnacipran Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090417</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022256</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>MILNACIPRAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Savella is indicated for the management of fibromyalgia. Savella is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor; it inhibits norepinephrine uptake with greater potency than serotonin. It is a racemic mixture with the chemical name: (±)-[1R(S),2S(R)]-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride. The structural formula is. Milnacipran hydrochloride is a white to off-white crystalline powder with a melting point of 179°C. It is freely soluble in water, methanol, ethanol, chloroform, and methylene chloride and sparingly soluble in diethyl ether. It has an empirical formula of C15H23ClN2O and a molecular weight of 282.8 g/mol. Savella is available for oral administration as film-coated tablets containing 12.5 mg, 25 mg, 50 mg, and 100 mg milnacipran hydrochloride. Each tablet also contains dibasic calcium phosphate, povidone, carboxymethylcellulose calcium, colloidal silicon dioxide, magnesium stearate, and talc as inactive ingredients. Additionally, the following inactive ingredients are also present as components of the film coat. 12.5 mg. FD&C Red #40 Aluminum Lake dye, hypromellose, polyethylene glycol, titanium dioxide. 25 mg. Hypromellose, polyethylene glycol, titanium dioxide. 50 mg. FD&C Blue #1, Blue #2, and Yellow #5 Aluminum Lake dyes; hypromellose; polyethylene glycol; titanium dioxide. 100 mg. FD&C Blue #1 Aluminum Lake dye, hypromellose, polyethylene glycol, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-846-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (31722-846-60) </PackageDescription>
<NDC11Code>31722-0846-60</NDC11Code>
<ProductNDC>31722-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Milnacipran Hydrochloride</ProprietaryName>
<NonProprietaryName>Milnacipran Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205147</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MILNACIPRAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Milnacipran hydrochloride tablets are indicated for the management of fibromyalgia. Milnacipran hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor; it inhibits norepinephrine uptake with greater potency than serotonin. The chemical name: (1R,2S)-rel-2- (Amino-methyl)-N,N-diethyl-1-phenylcyclo propane carboxamide hydrochloride. The structural formula is. Milnacipran hydrochloride is a white to off-white powder with a melting point of 179°C. It is freely soluble in water, methanol and in dimethysulphoxide, soluble in dimethyl formamide. It has an empirical formula of C 15H 22N 2O.HCl and a molecular weight of 282.81 g/mol. Milnacipran hydrochloride tablets are available for oral administration as film-coated tablets containing 12.5 mg, 25 mg, 50 mg, and 100 mg milnacipran hydrochloride. Each tablet also contains carboxymethylcellulose calcium, colloidal silicon dioxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc and titanium dioxide as inactive ingredients. Additionally, the 12.5 mg tablets contain FD & C Blue #2/Indigo Carmine Aluminum Lake and the 100 mg tablets contain FD&C Red #40 Allura Red AC-Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>35356-846-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (35356-846-60)</PackageDescription>
<NDC11Code>35356-0846-60</NDC11Code>
<ProductNDC>35356-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076639</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>45865-846-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (45865-846-60) </PackageDescription>
<NDC11Code>45865-0846-60</NDC11Code>
<ProductNDC>45865-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071009</StartMarketingDate>
<EndMarketingDate>20181031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077802</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>300</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>2018-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>49999-846-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (49999-846-60)</PackageDescription>
<NDC11Code>49999-0846-60</NDC11Code>
<ProductNDC>49999-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfateer</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076438</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-04-03</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52959-846-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 CONTAINER (52959-846-60) </PackageDescription>
<NDC11Code>52959-0846-60</NDC11Code>
<ProductNDC>52959-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078048</ApplicationNumber>
<LabelerName>H. J. Harkins Company Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20H21N HCl and a molecular weight of 311.9. It has a melting point of 217°C and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Each 5 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 5 mg Cyclobenzaprine hydrochloride. Each 10 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 10 mg Cyclobenzaprine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, carnauba wax, titanium dioxide, polyethylene glycol, and iron oxide yellow. In addition, 5 mg tablets also contain polyvinyl alcohol, talc, lecithin, and FD&C yellow # 6 / sunset yellow FCF aluminum lake. In addition, 10 mg tablets also contain D&C yellow # 10 aluminum lake, FD&C yellow # 6 aluminum lake and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>59779-846-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59779-846-06) > 60 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>59779-0846-06</NDC11Code>
<ProductNDC>59779-846</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diarrhea</ProprietaryName>
<NonProprietaryName>Cinchona Officinalis, Bryonia, Chamomilla, Colocynthis, Ipecacuanha, Belladonna</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140429</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>CVS PHARMACY</LabelerName>
<SubstanceName>CINCHONA OFFICINALIS BARK; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; ATROPA BELLADONNA</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of diarrhea. - diarrhea. - painful cramps. - nausea.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60429-846-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (60429-846-60) </PackageDescription>
<NDC11Code>60429-0846-60</NDC11Code>
<ProductNDC>60429-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valganciclovir</ProprietaryName>
<NonProprietaryName>Valganciclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203511</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>VALGANCICLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Valganciclovir tablets USP contains valganciclovir hydrochloride USP, a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir hydrochloride USP is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir hydrochloride USP (corresponding to 450 mg of valganciclovir), and the inactive ingredients crospovidone, magnesium stearate, microcrystalline cellulose and povidone. The film-coat applied to the tablets contains hypromellose, iron oxide red, polyethylene glycol, polysorbate and titanium dioxide. Valganciclovir hydrochloride USP is a white to almost white powder with a molecular formula of C 14H 22N 6O 5·HCl and a molecular weight of 390.71. The chemical name for valganciclovir hydrochloride USP is L-Valine, 2[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir hydrochloride USP is a polar hydrophilic compound with a saturation solubility of 6029 mg/mL in water at 25°C and an n-octanol/water partition coefficient of 0.00701 at pH 5.1. The pKa for valganciclovir hydrochloride USP is 7.2. The chemical structure of valganciclovir hydrochloride USP is. All doses in this insert are specified in terms of valganciclovir.</Description>
</NDC>
<NDC>
<NDCCode>60760-846-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (60760-846-60) </PackageDescription>
<NDC11Code>60760-0846-60</NDC11Code>
<ProductNDC>60760-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260318</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206943</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin capsules, USP are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: Pregelatinized Maize starch, talc, gelatin, titanium dioxide, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (300 mg and 400 mg only), black iron oxide (300 mg and 400 mg only). Ingredients of Imprinting Ink (Black SW-9049) are Black Iron Oxide NF (E 172), Butyl Alcohol NF, Dehydrated Alcohol USP, Isopropyl Alcohol USP, Potassium Hydroxide NF, Propylene Glycol USP, Shellac NF, and Strong Ammonia Solution NF.</Description>
</NDC>
<NDC>
<NDCCode>63187-846-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (63187-846-60) </PackageDescription>
<NDC11Code>63187-0846-60</NDC11Code>
<ProductNDC>63187-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071136</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The empirical formula is C16H13ClN2O and the molecular weight is 284.75. The structural formula is as follows. Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate and microcrystalline cellulose. Diazepam Tablets USP 5 mg also contain D&C Yellow No. 10. Diazepam Tablets USP 10 mg also contain FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>65841-846-14</NDCCode>
<PackageDescription>60 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-846-14) </PackageDescription>
<NDC11Code>65841-0846-14</NDC11Code>
<ProductNDC>65841-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078877</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-846-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71205-846-60) </PackageDescription>
<NDC11Code>71205-0846-60</NDC11Code>
<ProductNDC>71205-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>16.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Sedative 2. 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. C12H12N2O3 M.W. = 232.24 Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>71610-846-53</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71610-846-53) </PackageDescription>
<NDC11Code>71610-0846-53</NDC11Code>
<ProductNDC>71610-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216751</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Mirtazapine tablets, USP contain mirtazapine, USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the empirical formula of C 17H 19N 3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture:. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 mg or 30 mg of mirtazapine, and unscored film-coated tablets containing 7.5 mg or 45 mg of mirtazapine. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, and titanium dioxide. The 7.5 mg tablets also contain sunset yellow FCF lake and Allura red AC lake. The 15 mg tablets also contain iron oxide yellow, quinoline yellow lake and sunset yellow FCF lake. The 30 mg tablets also contain ferric oxide yellow, ferric oxide red and ferrosoferric oxide/iron oxide black. FDA approved dissolution method differs from the USP dissolution testing.</Description>
</NDC>
<NDC>
<NDCCode>76420-846-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (76420-846-60) </PackageDescription>
<NDC11Code>76420-0846-60</NDC11Code>
<ProductNDC>76420-846</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202413</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets, USP contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77°C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, soidum starch glycoate, stearic acid, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42291-033-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (42291-033-60) </PackageDescription>
<NDC11Code>42291-0033-60</NDC11Code>
<ProductNDC>42291-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213879</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days ( 1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4) .</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine,N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C 35H 45N 7O 8S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is:. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, soluble in ethanol, and practically insoluble in ethyl acetate. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, magnesium stearate, talc, tartaric acid pellets. The capsule shell is composed of hypromellose, titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>42291-034-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (42291-034-60) </PackageDescription>
<NDC11Code>42291-0034-60</NDC11Code>
<ProductNDC>42291-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213879</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days ( 1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4) .</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine,N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C 35H 45N 7O 8S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is:. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, soluble in ethanol, and practically insoluble in ethyl acetate. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, magnesium stearate, talc, tartaric acid pellets. The capsule shell is composed of hypromellose, titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>42291-043-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (42291-043-60) </PackageDescription>
<NDC11Code>42291-0043-60</NDC11Code>
<ProductNDC>42291-043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefdinir</ProprietaryName>
<NonProprietaryName>Cefdinir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065368</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>CEFDINIR</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
<Description>Cefdinir Capsules USP contain the active ingredient cefdinir, USP an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is (6 R,7 R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir,USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7.0 phosphate buffer. Cefdinir has the structural formula shown below:. C 14H 13N 5O 5S 2M.W. 395.41. Cefdinir Capsules USP contain 300 mg cefdinir, USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C green #3, FD&C red #40, FD&C red #40 aluminum lake, gelatin, iron oxide black, magnesium stearate, polyoxyl 40 stearate, propylene glycol, shellac glaze, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42291-073-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (42291-073-60) </PackageDescription>
<NDC11Code>42291-0073-60</NDC11Code>
<ProductNDC>42291-073</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208327</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC) .</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26H 33NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. .</Description>
</NDC>
<NDC>
<NDCCode>42291-076-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42291-076-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>42291-0076-60</NDC11Code>
<ProductNDC>42291-076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200618</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211256</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol propionate cream, USP 0.05% contains the active compound clobetasol propionate, USP, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate, USP, is pregna-1, 4-diene-3, 20-dione, 21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (11ß,16ß) and it has the following structural formula. Clobetasol propionate, USP has the empirical formula C 25H 32CIFO 5 and a molecular weight of 466.97. It is a white to almost white crystalline powder insoluble in water. Clobetasol propionate cream, USP, contains clobetasol propionate 0.5 mg/g in a cream base of anhydrous citric acid, cetyl alcohol, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide pellets may be used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>42291-077-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42291-077-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>42291-0077-60</NDC11Code>
<ProductNDC>42291-077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200618</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209701</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol Propionate Ointment USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol Propionate Ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate USP has the empirical formula C 25H 32ClFO 5 and a molecular weight of 466.97. It is a white to almost white, crystalline powder, practically insoluble in water; slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Clobetasol Propionate Ointment USP, 0.05% contains clobetasol propionate USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>42291-111-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-111-60)</PackageDescription>
<NDC11Code>42291-0111-60</NDC11Code>
<ProductNDC>42291-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078387</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-04-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-112-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-112-60)</PackageDescription>
<NDC11Code>42291-0112-60</NDC11Code>
<ProductNDC>42291-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078387</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-04-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-113-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-113-60)</PackageDescription>
<NDC11Code>42291-0113-60</NDC11Code>
<ProductNDC>42291-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078387</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-04-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-116-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (42291-116-60) </PackageDescription>
<NDC11Code>42291-0116-60</NDC11Code>
<ProductNDC>42291-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aspirin And Extended-release Dipyridamole</ProprietaryName>
<NonProprietaryName>Aspirin And Extended-release Dipyridamole</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206392</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ASPIRIN; DIPYRIDAMOLE</SubstanceName>
<StrengthNumber>25; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.</IndicationAndUsage>
<Description>Aspirin and extended-release dipyridamole is a combination antiplatelet agent intended for oral administration. Each hard gelatin capsule contains 200 mg dipyridamole, USP in an extended-release form and 25 mg aspirin USP, as an immediate-release sugar-coated tablet. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, hypromellose phthalate, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, simethicone, stearic acid, sucrose, talc, tartaric acid, triethyl citrate and triacetin. Each capsule shell contains D&C Yellow #10, gelatin, iron oxide red, iron oxide yellow, purified water, sodium lauryl sulfate and titanium dioxide. The imprinting inks contain butyl alcohol, D&C Yellow #10, dehydrated alcohol, FD&C Red #40, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dipyridamole, USP. Dipyridamole, USP is an antiplatelet agent chemically described as 2,2',2'',2'''-[(4,8-Dipiperidinopyrimido[5,4- d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula:. Dipyridamole, USP is an odorless yellow crystalline substance, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and is practically insoluble in water. Aspirin, USP. The antiplatelet agent aspirin, USP (acetylsalicylic acid) is chemically known as benzoic acid, 2- (acetyloxy)-, and has the following structural formula:. Aspirin, USP is an odorless white needle-like crystalline or powdery substance. When exposed to moisture, aspirin hydrolyzes into salicylic and acetic acids, and gives off a vinegary odor. It is highly lipid soluble and slightly soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>42291-148-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-148-60) </PackageDescription>
<NDC11Code>42291-0148-60</NDC11Code>
<ProductNDC>42291-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202984</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-154-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42291-154-60) </PackageDescription>
<NDC11Code>42291-0154-60</NDC11Code>
<ProductNDC>42291-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077563</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine hydrochloride tablets USP, for oral administration, are available in the following strengths: 5 mg, 7.5 mg and 10 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg tablet contain FD&C yellow # 6, and both the 5 mg and 10 mg tablets contain iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>42291-166-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (42291-166-60) </PackageDescription>
<NDC11Code>42291-0166-60</NDC11Code>
<ProductNDC>42291-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Capecitabine</ProprietaryName>
<NonProprietaryName>Capecitabine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204741</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>CAPECITABINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-190-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42291-190-60) </PackageDescription>
<NDC11Code>42291-0190-60</NDC11Code>
<ProductNDC>42291-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Capecitabine</ProprietaryName>
<NonProprietaryName>Capecitabine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091649</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>CAPECITABINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>