{
"NDC": [
{
"NDCCode": "66993-537-57",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (66993-537-57)",
"NDC11Code": "66993-0537-57",
"ProductNDC": "66993-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "R-tanna",
"ProprietaryNameSuffix": "Pediatric Suspension",
"NonProprietaryName": "Phenylephrine Tannate, Chlorpheniramine Tannate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "PHENYLEPHRINE TANNATE; CHLORPHENIRAMINE TANNATE",
"StrengthNumber": "5; 4.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "52125-537-57",
"PackageDescription": "5 mL in 1 BOTTLE (52125-537-57)",
"NDC11Code": "52125-0537-57",
"ProductNDC": "52125-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141017",
"EndMarketingDate": "20170825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077689",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "3.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "62032-537-58",
"PackageDescription": "1 KIT in 1 CARTON (62032-537-58) * 57 g in 1 BOTTLE, PLASTIC * 85 g in 1 TUBE * 177 mL in 1 BOTTLE, PLASTIC * 1 BOTTLE, GLASS in 1 CARTON > 30 mL in 1 BOTTLE, GLASS * 57 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "62032-0537-58",
"ProductNDC": "62032-537",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Obagi-c Fx System Normal-dry",
"ProprietaryNameSuffix": "Skin Brightening System With Arbutin",
"NonProprietaryName": "Homosalate, Octisalate, And Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Obagi Cosmeceuticals LLC",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20191202",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "66993-118-57",
"PackageDescription": "473 mL in 1 BOTTLE (66993-118-57) ",
"NDC11Code": "66993-0118-57",
"ProductNDC": "66993-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
"NonProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
"DosageFormName": "ELIXIR",
"RouteName": "ORAL",
"StartMarketingDate": "20191118",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
"StrengthNumber": "16.2; .1307; .0194; .0065",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20191118",
"SamplePackage": "N"
},
{
"NDCCode": "66993-119-57",
"PackageDescription": "473 mL in 1 BOTTLE (66993-119-57) ",
"NDC11Code": "66993-0119-57",
"ProductNDC": "66993-119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
"NonProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
"DosageFormName": "ELIXIR",
"RouteName": "ORAL",
"StartMarketingDate": "20191118",
"EndMarketingDate": "20211130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
"StrengthNumber": "16.2; .1307; .0194; .0065",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191118",
"EndMarketingDatePackage": "20211130",
"SamplePackage": "N"
},
{
"NDCCode": "66993-359-57",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (66993-359-57) ",
"NDC11Code": "66993-0359-57",
"ProductNDC": "66993-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040776",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140515",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine Sulfate Oral Solution is indicated in:. Narcolepsy. Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, hyperactivity, emotionally lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.",
"Description": "Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate as the neutral sulfate. Structural Formula:. Dextroamphetamine Sulfate Oral Solution is a colorless, bubblegum flavored oral solution. Each teaspoonful (5 mL) of Dextroamphetamine Sulfate Oral Solution contains 5 mg of dextroamphetamine sulfate. Inactive ingredients consist of benzoic acid, citric acid anhydrous, purified water, sodium citrate hydrous, sodium saccharin, sorbitol solution, and artificial bubblegum flavor."
},
{
"NDCCode": "66993-727-57",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (66993-727-57) ",
"NDC11Code": "66993-0727-57",
"ProductNDC": "66993-727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077612",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "200; 40",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220705",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim oral suspension is a synthetic antibacterial combination product available in a suspension for oral administration, with each teaspoonful (5 mL) containing 200 mg sulfamethoxazole and 40 mg trimethoprim. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: alcohol 0.03% (v/v), methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid, glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, sorbitol solution, FD&C Red No. 40 and cherry flavoring."
},
{
"NDCCode": "16714-537-01",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (16714-537-01) ",
"NDC11Code": "16714-0537-01",
"ProductNDC": "16714-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220329",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc) 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
},
{
"NDCCode": "16714-537-02",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (16714-537-02) ",
"NDC11Code": "16714-0537-02",
"ProductNDC": "16714-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220329",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc) 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
},
{
"NDCCode": "31722-537-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (31722-537-05) ",
"NDC11Code": "31722-0537-05",
"ProductNDC": "31722-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101008",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
},
{
"NDCCode": "31722-537-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-537-10) ",
"NDC11Code": "31722-0537-10",
"ProductNDC": "31722-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101008",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
},
{
"NDCCode": "31722-537-12",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (31722-537-12) ",
"NDC11Code": "31722-0537-12",
"ProductNDC": "31722-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101008",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
},
{
"NDCCode": "31722-537-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (31722-537-30) ",
"NDC11Code": "31722-0537-30",
"ProductNDC": "31722-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101008",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
},
{
"NDCCode": "31722-537-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (31722-537-60) ",
"NDC11Code": "31722-0537-60",
"ProductNDC": "31722-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101008",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
},
{
"NDCCode": "10544-537-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (10544-537-30)",
"NDC11Code": "10544-0537-30",
"ProductNDC": "10544-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071851",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "TRIAMTERENE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "75; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).",
"Description": "Triamterene and hydrochlorothiazide tablets USP, combines triamterene, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Triamterene and hydrochlorothiazide tablets are available in two strengths. Each triamterene and hydrochlorothiazide tablet, 75 mg/50 mg, contains triamterene USP, 75 mg and hydrochlorothiazide USP, 50 mg. Each triamterene and hydrochlorothazide tablet, 37.5 mg/25 mg, contains triamterene USP, 37.5 mg and hydrochlorothiazide USP, 25 mg. Both strengths of triamterene and hydrochlorothiazide tablets for oral administration contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 8000, povidone, and magnesium stearate. Triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg also contain FD&C Blue #2. Triamterene is 2, 4, 7-triamino-6-phenylpteridine. Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids. Its molecular weight is 253.27. Its structural formula is. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1, 2, 4-benzothiadiazine-7-sulfonamide 1, 1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. Its structural formula is:."
},
{
"NDCCode": "10685-537-11",
"PackageDescription": "208000 mL in 1 DRUM (10685-537-11) ",
"NDC11Code": "10685-0537-11",
"ProductNDC": "10685-537",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pc537 E-2 Brute",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131016",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "CARROLL COMPANY",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "25",
"StrengthUnit": "g/1000mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20131016",
"SamplePackage": "N",
"IndicationAndUsage": "skin cleanser and sanitizer."
},
{
"NDCCode": "10685-537-28",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (10685-537-28) ",
"NDC11Code": "10685-0537-28",
"ProductNDC": "10685-537",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pc537 E-2 Brute",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131016",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "CARROLL COMPANY",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "25",
"StrengthUnit": "g/1000mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20131016",
"SamplePackage": "N",
"IndicationAndUsage": "skin cleanser and sanitizer."
},
{
"NDCCode": "10812-537-01",
"PackageDescription": "1 JAR in 1 CARTON (10812-537-01) / 48 g in 1 JAR",
"NDC11Code": "10812-0537-01",
"ProductNDC": "10812-537",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Triple Age Repair Moisturizer",
"ProprietaryNameSuffix": "Broad Spectrum Spf25",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131001",
"EndMarketingDate": "20230824",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "20; 40; 40; 20",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131001",
"EndMarketingDatePackage": "20230824",
"SamplePackage": "N"
},
{
"NDCCode": "11084-537-27",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (11084-537-27)",
"NDC11Code": "11084-0537-27",
"ProductNDC": "11084-537",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Delta Foremost Antibac",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130705",
"EndMarketingDate": "20200801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Deb USA, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".3",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-04",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "12634-537-00",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-00)",
"NDC11Code": "12634-0537-00",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-01)",
"NDC11Code": "12634-0537-01",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-55",
"PackageDescription": "15 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-55)",
"NDC11Code": "12634-0537-55",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-60)",
"NDC11Code": "12634-0537-60",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-69",
"PackageDescription": "9 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-69)",
"NDC11Code": "12634-0537-69",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-71",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-71)",
"NDC11Code": "12634-0537-71",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-80",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-80)",
"NDC11Code": "12634-0537-80",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-82",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-82)",
"NDC11Code": "12634-0537-82",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-85",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-85)",
"NDC11Code": "12634-0537-85",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-91",
"PackageDescription": "1 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-91)",
"NDC11Code": "12634-0537-91",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-98",
"PackageDescription": "8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-98)",
"NDC11Code": "12634-0537-98",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
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"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
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"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
}
]
}
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040776</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine Sulfate Oral Solution is indicated in:. Narcolepsy. Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, hyperactivity, emotionally lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.</IndicationAndUsage>
<Description>Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate as the neutral sulfate. Structural Formula:. Dextroamphetamine Sulfate Oral Solution is a colorless, bubblegum flavored oral solution. Each teaspoonful (5 mL) of Dextroamphetamine Sulfate Oral Solution contains 5 mg of dextroamphetamine sulfate. Inactive ingredients consist of benzoic acid, citric acid anhydrous, purified water, sodium citrate hydrous, sodium saccharin, sorbitol solution, and artificial bubblegum flavor.</Description>
</NDC>
<NDC>
<NDCCode>66993-727-57</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (66993-727-57) </PackageDescription>
<NDC11Code>66993-0727-57</NDC11Code>
<ProductNDC>66993-727</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077612</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>200; 40</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim oral suspension is a synthetic antibacterial combination product available in a suspension for oral administration, with each teaspoonful (5 mL) containing 200 mg sulfamethoxazole and 40 mg trimethoprim. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: alcohol 0.03% (v/v), methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid, glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, sorbitol solution, FD&C Red No. 40 and cherry flavoring.</Description>
</NDC>
<NDC>
<NDCCode>16714-537-01</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (16714-537-01) </PackageDescription>
<NDC11Code>16714-0537-01</NDC11Code>
<ProductNDC>16714-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc) 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
<NDC>
<NDCCode>16714-537-02</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16714-537-02) </PackageDescription>
<NDC11Code>16714-0537-02</NDC11Code>
<ProductNDC>16714-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc) 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
<NDC>
<NDCCode>31722-537-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (31722-537-05) </PackageDescription>
<NDC11Code>31722-0537-05</NDC11Code>
<ProductNDC>31722-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
<NDC>
<NDCCode>31722-537-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (31722-537-10) </PackageDescription>
<NDC11Code>31722-0537-10</NDC11Code>
<ProductNDC>31722-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
<NDC>
<NDCCode>31722-537-12</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (31722-537-12) </PackageDescription>
<NDC11Code>31722-0537-12</NDC11Code>
<ProductNDC>31722-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
<NDC>
<NDCCode>31722-537-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (31722-537-30) </PackageDescription>
<NDC11Code>31722-0537-30</NDC11Code>
<ProductNDC>31722-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
<NDC>
<NDCCode>31722-537-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (31722-537-60) </PackageDescription>
<NDC11Code>31722-0537-60</NDC11Code>
<ProductNDC>31722-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
<NDC>
<NDCCode>10544-537-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (10544-537-30)</PackageDescription>
<NDC11Code>10544-0537-30</NDC11Code>
<ProductNDC>10544-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071851</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>75; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).</IndicationAndUsage>
<Description>Triamterene and hydrochlorothiazide tablets USP, combines triamterene, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Triamterene and hydrochlorothiazide tablets are available in two strengths. Each triamterene and hydrochlorothiazide tablet, 75 mg/50 mg, contains triamterene USP, 75 mg and hydrochlorothiazide USP, 50 mg. Each triamterene and hydrochlorothazide tablet, 37.5 mg/25 mg, contains triamterene USP, 37.5 mg and hydrochlorothiazide USP, 25 mg. Both strengths of triamterene and hydrochlorothiazide tablets for oral administration contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 8000, povidone, and magnesium stearate. Triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg also contain FD&C Blue #2. Triamterene is 2, 4, 7-triamino-6-phenylpteridine. Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids. Its molecular weight is 253.27. Its structural formula is. Hydrochlorothiazide is 6-chloro-3, 4-dihydro-2 H-1, 2, 4-benzothiadiazine-7-sulfonamide 1, 1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. Its structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>10685-537-11</NDCCode>
<PackageDescription>208000 mL in 1 DRUM (10685-537-11) </PackageDescription>
<NDC11Code>10685-0537-11</NDC11Code>
<ProductNDC>10685-537</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pc537 E-2 Brute</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131016</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>CARROLL COMPANY</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/1000mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>skin cleanser and sanitizer.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10685-537-28</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (10685-537-28) </PackageDescription>
<NDC11Code>10685-0537-28</NDC11Code>
<ProductNDC>10685-537</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pc537 E-2 Brute</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131016</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>CARROLL COMPANY</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/1000mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>skin cleanser and sanitizer.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10812-537-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (10812-537-01) / 48 g in 1 JAR</PackageDescription>
<NDC11Code>10812-0537-01</NDC11Code>
<ProductNDC>10812-537</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Triple Age Repair Moisturizer</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf25</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131001</StartMarketingDate>
<EndMarketingDate>20230824</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>20; 40; 40; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131001</StartMarketingDatePackage>
<EndMarketingDatePackage>20230824</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11084-537-27</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (11084-537-27)</PackageDescription>
<NDC11Code>11084-0537-27</NDC11Code>
<ProductNDC>11084-537</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Delta Foremost Antibac</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130705</StartMarketingDate>
<EndMarketingDate>20200801</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Deb USA, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>12634-537-00</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-00)</PackageDescription>
<NDC11Code>12634-0537-00</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-01)</PackageDescription>
<NDC11Code>12634-0537-01</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-55</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-55)</PackageDescription>
<NDC11Code>12634-0537-55</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-60)</PackageDescription>
<NDC11Code>12634-0537-60</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-69</NDCCode>
<PackageDescription>9 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-69)</PackageDescription>
<NDC11Code>12634-0537-69</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-71</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-71)</PackageDescription>
<NDC11Code>12634-0537-71</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-80</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-80)</PackageDescription>
<NDC11Code>12634-0537-80</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-82</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-82)</PackageDescription>
<NDC11Code>12634-0537-82</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-85</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-85)</PackageDescription>
<NDC11Code>12634-0537-85</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-91</NDCCode>
<PackageDescription>1 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-91)</PackageDescription>
<NDC11Code>12634-0537-91</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-98</NDCCode>
<PackageDescription>8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-98)</PackageDescription>
<NDC11Code>12634-0537-98</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
</NDCList>