{
"NDC": [
{
"NDCCode": "68387-531-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (68387-531-60)",
"NDC11Code": "68387-0531-60",
"ProductNDC": "68387-531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pentazocine And Naloxone",
"NonProprietaryName": "Pentazocine Hydrochloride And Naloxone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074736",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
"StrengthNumber": "50; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain. Pentazocine and naloxone hydrochlorides tablets are indicated for oral use only.",
"Description": "Pentazocine and naloxone hydrochlorides tablets USP contain pentazocine hydrochloride USP, equivalent to 50 mg base, a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride USP, equivalent to 0.5 mg base. Pentazocine and naloxone hydrochlorides tablets are an analgesic for oral administration. Chemically, pentazocine hydrochloride is (2R*, 6R*, 11R*)-1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions. It has the following structural formula. Chemically, naloxone hydrochloride is 17-AIlyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. It is a slightly off-white powder, and is soluble in water and dilute acids. It has the following structural formula. Each tablet, for oral administration, contains pentazocine hydrochloride USP, equivalent to 50 mg of pentazocine, and naloxone hydrochloride USP, equivalent to 0.5 mg of naloxone. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D&C Yellow No. 10 Al-lake, FD&C Blue No. 1 Al-lake, FD&C Yellow No. 6 Al-lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate."
},
{
"NDCCode": "68387-531-12",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (68387-531-12)",
"NDC11Code": "68387-0531-12",
"ProductNDC": "68387-531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pentazocine And Naloxone",
"NonProprietaryName": "Pentazocine Hydrochloride And Naloxone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074736",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
"StrengthNumber": "50; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain. Pentazocine and naloxone hydrochlorides tablets are indicated for oral use only.",
"Description": "Pentazocine and naloxone hydrochlorides tablets USP contain pentazocine hydrochloride USP, equivalent to 50 mg base, a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride USP, equivalent to 0.5 mg base. Pentazocine and naloxone hydrochlorides tablets are an analgesic for oral administration. Chemically, pentazocine hydrochloride is (2R*, 6R*, 11R*)-1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions. It has the following structural formula. Chemically, naloxone hydrochloride is 17-AIlyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. It is a slightly off-white powder, and is soluble in water and dilute acids. It has the following structural formula. Each tablet, for oral administration, contains pentazocine hydrochloride USP, equivalent to 50 mg of pentazocine, and naloxone hydrochloride USP, equivalent to 0.5 mg of naloxone. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D&C Yellow No. 10 Al-lake, FD&C Blue No. 1 Al-lake, FD&C Yellow No. 6 Al-lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate."
},
{
"NDCCode": "68387-531-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (68387-531-30)",
"NDC11Code": "68387-0531-30",
"ProductNDC": "68387-531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pentazocine And Naloxone",
"NonProprietaryName": "Pentazocine Hydrochloride And Naloxone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074736",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
"StrengthNumber": "50; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain. Pentazocine and naloxone hydrochlorides tablets are indicated for oral use only.",
"Description": "Pentazocine and naloxone hydrochlorides tablets USP contain pentazocine hydrochloride USP, equivalent to 50 mg base, a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride USP, equivalent to 0.5 mg base. Pentazocine and naloxone hydrochlorides tablets are an analgesic for oral administration. Chemically, pentazocine hydrochloride is (2R*, 6R*, 11R*)-1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions. It has the following structural formula. Chemically, naloxone hydrochloride is 17-AIlyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. It is a slightly off-white powder, and is soluble in water and dilute acids. It has the following structural formula. Each tablet, for oral administration, contains pentazocine hydrochloride USP, equivalent to 50 mg of pentazocine, and naloxone hydrochloride USP, equivalent to 0.5 mg of naloxone. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D&C Yellow No. 10 Al-lake, FD&C Blue No. 1 Al-lake, FD&C Yellow No. 6 Al-lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate."
},
{
"NDCCode": "10544-531-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (10544-531-60)",
"NDC11Code": "10544-0531-60",
"ProductNDC": "10544-531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076003",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tramadol hydrochloride is indicated for the management of moderate to moderately severe pain in adults.",
"Description": "Tramadol hydrochloride tablets is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular formula of tramadol hydrochloride is C16H25NO2HCl and its molecular weight is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Each tramadol hydrochloride tablet intended for oral administration contains 50 mg of tramadol hydrochloride. In addition, it also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "12634-531-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (12634-531-60)",
"NDC11Code": "12634-0531-60",
"ProductNDC": "12634-531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
"NonProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19771117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085762",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE",
"StrengthNumber": "2.5; .025",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "Diphenoxylate hydrochloride and atropine sulfate tablets, USP are effective as adjunctive therapy in the management of diarrhea.",
"Description": "Each tablet for oral administration contains. Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3, 3-diphenylpropyl)-4-phenyl-isonipecotate monohydrochloride and has the following structure. Atropine sulfate, an anticholinergic, is endo-(±)-alpha-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicylo[3.2.1] oct-3-yl ester sulfate (2:1)] (salt) monohydrate and has the following structure. A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid."
},
{
"NDCCode": "37205-531-72",
"PackageDescription": "1 BOTTLE in 1 CARTON (37205-531-72) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "37205-0531-72",
"ProductNDC": "37205-531",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Acid Control",
"ProprietaryNameSuffix": "Acid Reducer",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076760",
"LabelerName": "Cardinal Health",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "43063-531-60",
"PackageDescription": "60 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-531-60)",
"NDC11Code": "43063-0531-60",
"ProductNDC": "43063-531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xartemis",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130430",
"EndMarketingDate": "20190531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204031",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-31",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "58411-531-60",
"PackageDescription": "1 TUBE in 1 CARTON (58411-531-60) > 50 mL in 1 TUBE",
"NDC11Code": "58411-0531-60",
"ProductNDC": "58411-531",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laura Mercier Tinted Moisturizer Broad Spectrum Spf 30 Sunscreen - 6c1 Cacao",
"NonProprietaryName": "Avobenzone, Octinoxate, Oxybenzone, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Laura Mercier Cosmetics",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OXYBENZONE; OCTOCRYLENE",
"StrengthNumber": "1.25; 3.745; .5; 1",
"StrengthUnit": "g/50mL; g/50mL; g/50mL; g/50mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N"
},
{
"NDCCode": "60429-531-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (60429-531-60)",
"NDC11Code": "60429-0531-60",
"ProductNDC": "60429-531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080222",
"EndMarketingDate": "20140830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078184",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-09-05"
},
{
"NDCCode": "68462-531-65",
"PackageDescription": "60 g in 1 TUBE (68462-531-65) ",
"NDC11Code": "68462-0531-65",
"ProductNDC": "68462-531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202838",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130920",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone USP. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone ointment USP, 0.25% contains 2.5 mg of desoximetasone USP in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone USP is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone USP has the molecular formula C22H29FO4 and a molecular weight of 376.46. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "70934-531-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (70934-531-60) ",
"NDC11Code": "70934-0531-60",
"ProductNDC": "70934-531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075964",
"LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200131",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated. , 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia. .",
"Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadolhydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80."
},
{
"NDCCode": "71205-531-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (71205-531-60) ",
"NDC11Code": "71205-0531-60",
"ProductNDC": "71205-531",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hcl",
"NonProprietaryName": "Fexofenadine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204097",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210203",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. § runny nose. § sneezing. § itchy, watery eyes. § itching of the nose or throat."
},
{
"NDCCode": "71610-531-53",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (71610-531-53) ",
"NDC11Code": "71610-0531-53",
"ProductNDC": "71610-531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190808",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040245",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210310",
"SamplePackage": "N",
"IndicationAndUsage": "Carisoprodol Tablets USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see Dosage and Administration (2)].",
"Description": "Carisoprodol Tablets USP are available as 350 mg round, white tablets for oral administration. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in Carisoprodol Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "71610-531-60",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (71610-531-60) ",
"NDC11Code": "71610-0531-60",
"ProductNDC": "71610-531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190808",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040245",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210407",
"SamplePackage": "N",
"IndicationAndUsage": "Carisoprodol Tablets USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see Dosage and Administration (2)].",
"Description": "Carisoprodol Tablets USP are available as 350 mg round, white tablets for oral administration. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in Carisoprodol Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "76494-531-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (76494-531-06) ",
"NDC11Code": "76494-0531-06",
"ProductNDC": "76494-531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078106",
"LabelerName": "Prinston Pharmaceutical Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2020-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120911",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam is an antiepileptic drug indicated for adjunctive therapy in the treatment of: 1 Partial onset seizures in patients four years of age and older with epilepsy (1.1), 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 3 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 (pink), 500 mg (pink), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of Levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc, and additional agents listed below. USP dissolution test is pending."
},
{
"NDCCode": "68387-100-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68387-100-60)",
"NDC11Code": "68387-0100-60",
"ProductNDC": "68387-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074843",
"LabelerName": "Keltman Pharmaceuticals 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",
"IndicationAndUsage": "Propoxyphene napsylate and acetaminophen tablets, USP are indicated for the relief of mild to moderate pain.",
"Description": "Propoxyphene Napsylate, USP is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water and soluble in methanol, ethanol, chloroform, and acetone. Chemically, it is (αS,1R)-α-[2-(Dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-napthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. 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. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula. Propoxyphene Napsylate and Acetaminophen Tablets, USP 50 mg/325 mgEach tablet contains: Propoxyphene Napsylate ............................50 mg (88.4 μmol) Acetaminophen .........................................325 mg (2150 μmol) In addition each tablet contains the following inactive ingredients: carnauba wax, D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide. Propoxyphene Napsylate and Acetaminophen Tablets, USP 100 mg/650 mgEach tablet contains: Propoxyphene Napsylate ...........................100 mg (176.8 μmol) Acetaminophen ..........................................650 mg (4300 μmol)In addition each tablet contains the following inactive ingredients: carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide. The orange tablets also contain D&C Yellow #10 Aluminum Lake and FD&C Red #40 Aluminum Lake. The pink tablets also contain FD&C Red #40 Aluminum Lake."
},
{
"NDCCode": "68387-108-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (68387-108-60)",
"NDC11Code": "68387-0108-60",
"ProductNDC": "68387-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metaxalone",
"NonProprietaryName": "Metaxalone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040486",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "METAXALONE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metaxalone tablets are indicated as an adjunct to rest, physical therapy and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.",
"Description": "Metaxalone tablets are available as an 800 mg tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy)methyl]-2-oxazolidinone. The empirical formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is. Metaxalone is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: alginic acid, ammonium calcium alginate, B-Rose Liquid, corn starch and magnesium stearate."
},
{
"NDCCode": "68387-140-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (68387-140-60)",
"NDC11Code": "68387-0140-60",
"ProductNDC": "68387-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine Hydrochloride",
"NonProprietaryName": "Tizanidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076347",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tizanidine hydrochloride is a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).",
"Description": "Tizanidine hydrochloride is a centrally acting α2-adrenergic agonist. Tizanidine hydrochloride, USP is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine’s molecular formula is C9H8ClN5S·HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine tablets, USP are supplied 4 mg tablets for oral administration. Tizanidine tablets are composed of the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base and 4.576 mg equivalent to 4 mg tizanidine base), and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose, pregelatinized Starch and stearic acid."
},
{
"NDCCode": "68387-165-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (68387-165-60)",
"NDC11Code": "68387-0165-60",
"ProductNDC": "68387-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072192",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Trazodone hydrochloride tablets are indicated for the treatment of depression. The efficacy of trazodone has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association's Diagnostic and Statistical Manual, III.a. Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least two weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.",
"Description": "Trazodone hydrochloride is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl] propyl]-1,2,4-triazolo[4,3-a]pyridin-3 (2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. It has a structural formula as follows. Each tablet for oral administration contains 50 mg or 100 mg of trazodone hydrochloride. Trazodone hydrochloride tablets 50 mg and 100 mg contain the inactive ingredients hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, and titanium dioxide."
},
{
"NDCCode": "68387-210-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (68387-210-60)",
"NDC11Code": "68387-0210-60",
"ProductNDC": "68387-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
},
{
"NDCCode": "68387-230-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (68387-230-60)",
"NDC11Code": "68387-0230-60",
"ProductNDC": "68387-230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089699",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.",
"Description": "Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α- Epoxy-3-methoxy-17-methylmorphinan- 6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4’-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Hydrocodone bitartrate and acetaminophen tablets, USP for oral administration are available in a variety of strength as described in the following table. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, starch, and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "68387-235-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (68387-235-60)",
"NDC11Code": "68387-0235-60",
"ProductNDC": "68387-235",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040746",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains. Hydrocodone Bitartrate, USP ......................... 10 mg. Acetaminophen, USP .................................... 325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. Meets USP Dissolution Test 1."
},
{
"NDCCode": "68387-250-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (68387-250-60)",
"NDC11Code": "68387-0250-60",
"ProductNDC": "68387-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089805",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.",
"Description": "Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each 300 mg/30 mg Acetaminophen and Codeine Phosphate Tablet contains: Acetaminophen ......................................................................................................300 mg Codeine Phosphate ..................................................................................................30 mg. Each 300 mg/60 mg Acetaminophen and Codeine Phosphate Tablet contains: Acetaminophen ......................................................................................................300 mg Codeine Phosphate ..................................................................................................60 mg."
},
{
"NDCCode": "68387-260-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68387-260-60)",
"NDC11Code": "68387-0260-60",
"ProductNDC": "68387-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077863",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium delayed-release tablets, are indicated: 1 For relief of signs and symptoms of osteoarthritis, 2 For relief of signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
"Description": "Diclofenac sodium delayed-release tablets are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets are available as delayed-release tablets of 75 mg for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in Diclofenac sodium delayed-release tablets include: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, opadry brown (Titanium dioxide, hypromellose, polyethylene glycol, iron oxide red, iron oxide yellow) and purified water."
},
{
"NDCCode": "68387-310-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68387-310-60)",
"NDC11Code": "68387-0310-60",
"ProductNDC": "68387-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine Hydrochloride",
"NonProprietaryName": "Ranitidine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074467",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ranitidine is indicated in: 1 Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year., 3 The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg two times a day., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.",
"Description": "Ranitidine hydrochloride (HCl), is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The empirical formula is C13H22N4O3S HCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur like odor. Each tablet, for oral administration contains 168 mg or 336 mg of ranitidine hydrochloride equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: D & C Red #30 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, triethyl citrate, sodium starch glycolate, titanium dioxide and flavoring. The 300 mg also contains: D & C Yellow #10 Aluminum Lake. Each capsule, for oral administration contains 168 mg or 336 mg of ranitidine hydrochloride equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: Ammonium hydroxide, colloidal silicon dioxide, corn starch, FD & C Blue #1, FD & C Red #40, FD & C Yellow #6, gelatin, magnesium stearate, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "68387-340-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (68387-340-60)",
"NDC11Code": "68387-0340-60",
"ProductNDC": "68387-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085159",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is. The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate."
},
{
"NDCCode": "68387-342-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (68387-342-60)",
"NDC11Code": "68387-0342-60",
"ProductNDC": "68387-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085159",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is. The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate."
},
{
"NDCCode": "68387-404-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (68387-404-60)",
"NDC11Code": "68387-0404-60",
"ProductNDC": "68387-404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078428",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Postherpetic Neuralgia. Gabapentin Capsules is indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin Capsules is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin Capsules is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.",
"Description": "Gabapentin Capsules are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin. The inactive ingredients for the capsules are magnesium stearate, pregelatinized starch, starch and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No.6 and FD&C Blue No.1. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25."
},
{
"NDCCode": "68387-410-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (68387-410-60)",
"NDC11Code": "68387-0410-60",
"ProductNDC": "68387-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078428",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Postherpetic Neuralgia. Gabapentin Capsules is indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin Capsules is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin Capsules is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.",
"Description": "Gabapentin Capsules are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin. The inactive ingredients for the capsules are magnesium stearate, pregelatinized starch, starch and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No.6 and FD&C Blue No.1. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25."
},
{
"NDCCode": "68387-497-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (68387-497-60)",
"NDC11Code": "68387-0497-60",
"ProductNDC": "68387-497",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076475",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "37.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, are indicated for the short-term (five days or less) management of acute pain.",
"Description": "Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, combines two analgesics, tramadol and acetaminophen. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are orange in color. Tramadol hydrochloride and acetaminophen tablets are intended for oral administration. Inactive ingredients in the tablet are crospovidone, magnesium stearate, microcrystalline cellulose, OPADRY® II Orange, povidone, pregelatinized starch, purified water, and stearic acid. OPADRY® II Orange contains: FD&C red #40; FD&C yellow #6; hypromellose 2910 3cP, 6cP, and 50cP; polydextrose; polyethylene glycol; titanium dioxide; triacetate; and triacetin."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68387-531-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (68387-531-60)</PackageDescription>
<NDC11Code>68387-0531-60</NDC11Code>
<ProductNDC>68387-531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentazocine And Naloxone</ProprietaryName>
<NonProprietaryName>Pentazocine Hydrochloride And Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074736</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain. Pentazocine and naloxone hydrochlorides tablets are indicated for oral use only.</IndicationAndUsage>
<Description>Pentazocine and naloxone hydrochlorides tablets USP contain pentazocine hydrochloride USP, equivalent to 50 mg base, a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride USP, equivalent to 0.5 mg base. Pentazocine and naloxone hydrochlorides tablets are an analgesic for oral administration. Chemically, pentazocine hydrochloride is (2R*, 6R*, 11R*)-1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions. It has the following structural formula. Chemically, naloxone hydrochloride is 17-AIlyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. It is a slightly off-white powder, and is soluble in water and dilute acids. It has the following structural formula. Each tablet, for oral administration, contains pentazocine hydrochloride USP, equivalent to 50 mg of pentazocine, and naloxone hydrochloride USP, equivalent to 0.5 mg of naloxone. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D&C Yellow No. 10 Al-lake, FD&C Blue No. 1 Al-lake, FD&C Yellow No. 6 Al-lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>68387-531-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (68387-531-12)</PackageDescription>
<NDC11Code>68387-0531-12</NDC11Code>
<ProductNDC>68387-531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentazocine And Naloxone</ProprietaryName>
<NonProprietaryName>Pentazocine Hydrochloride And Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074736</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain. Pentazocine and naloxone hydrochlorides tablets are indicated for oral use only.</IndicationAndUsage>
<Description>Pentazocine and naloxone hydrochlorides tablets USP contain pentazocine hydrochloride USP, equivalent to 50 mg base, a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride USP, equivalent to 0.5 mg base. Pentazocine and naloxone hydrochlorides tablets are an analgesic for oral administration. Chemically, pentazocine hydrochloride is (2R*, 6R*, 11R*)-1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions. It has the following structural formula. Chemically, naloxone hydrochloride is 17-AIlyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. It is a slightly off-white powder, and is soluble in water and dilute acids. It has the following structural formula. Each tablet, for oral administration, contains pentazocine hydrochloride USP, equivalent to 50 mg of pentazocine, and naloxone hydrochloride USP, equivalent to 0.5 mg of naloxone. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D&C Yellow No. 10 Al-lake, FD&C Blue No. 1 Al-lake, FD&C Yellow No. 6 Al-lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>68387-531-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (68387-531-30)</PackageDescription>
<NDC11Code>68387-0531-30</NDC11Code>
<ProductNDC>68387-531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentazocine And Naloxone</ProprietaryName>
<NonProprietaryName>Pentazocine Hydrochloride And Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074736</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain. Pentazocine and naloxone hydrochlorides tablets are indicated for oral use only.</IndicationAndUsage>
<Description>Pentazocine and naloxone hydrochlorides tablets USP contain pentazocine hydrochloride USP, equivalent to 50 mg base, a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride USP, equivalent to 0.5 mg base. Pentazocine and naloxone hydrochlorides tablets are an analgesic for oral administration. Chemically, pentazocine hydrochloride is (2R*, 6R*, 11R*)-1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions. It has the following structural formula. Chemically, naloxone hydrochloride is 17-AIlyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. It is a slightly off-white powder, and is soluble in water and dilute acids. It has the following structural formula. Each tablet, for oral administration, contains pentazocine hydrochloride USP, equivalent to 50 mg of pentazocine, and naloxone hydrochloride USP, equivalent to 0.5 mg of naloxone. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D&C Yellow No. 10 Al-lake, FD&C Blue No. 1 Al-lake, FD&C Yellow No. 6 Al-lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>10544-531-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (10544-531-60)</PackageDescription>
<NDC11Code>10544-0531-60</NDC11Code>
<ProductNDC>10544-531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076003</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tramadol hydrochloride is indicated for the management of moderate to moderately severe pain in adults.</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular formula of tramadol hydrochloride is C16H25NO2HCl and its molecular weight is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Each tramadol hydrochloride tablet intended for oral administration contains 50 mg of tramadol hydrochloride. In addition, it also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>12634-531-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (12634-531-60)</PackageDescription>
<NDC11Code>12634-0531-60</NDC11Code>
<ProductNDC>12634-531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19771117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085762</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE</SubstanceName>
<StrengthNumber>2.5; .025</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diphenoxylate hydrochloride and atropine sulfate tablets, USP are effective as adjunctive therapy in the management of diarrhea.</IndicationAndUsage>
<Description>Each tablet for oral administration contains. Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3, 3-diphenylpropyl)-4-phenyl-isonipecotate monohydrochloride and has the following structure. Atropine sulfate, an anticholinergic, is endo-(±)-alpha-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicylo[3.2.1] oct-3-yl ester sulfate (2:1)] (salt) monohydrate and has the following structure. A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>37205-531-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (37205-531-72) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>37205-0531-72</NDC11Code>
<ProductNDC>37205-531</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Acid Control</ProprietaryName>
<ProprietaryNameSuffix>Acid Reducer</ProprietaryNameSuffix>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076760</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>43063-531-60</NDCCode>
<PackageDescription>60 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-531-60)</PackageDescription>
<NDC11Code>43063-0531-60</NDC11Code>
<ProductNDC>43063-531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xartemis</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130430</StartMarketingDate>
<EndMarketingDate>20190531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204031</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>58411-531-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-531-60) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0531-60</NDC11Code>
<ProductNDC>58411-531</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laura Mercier Tinted Moisturizer Broad Spectrum Spf 30 Sunscreen - 6c1 Cacao</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate, Oxybenzone, And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Laura Mercier Cosmetics</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OXYBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1.25; 3.745; .5; 1</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60429-531-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (60429-531-60)</PackageDescription>
<NDC11Code>60429-0531-60</NDC11Code>
<ProductNDC>60429-531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080222</StartMarketingDate>
<EndMarketingDate>20140830</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078184</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-09-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>68462-531-65</NDCCode>
<PackageDescription>60 g in 1 TUBE (68462-531-65) </PackageDescription>
<NDC11Code>68462-0531-65</NDC11Code>
<ProductNDC>68462-531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130920</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202838</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone USP. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone ointment USP, 0.25% contains 2.5 mg of desoximetasone USP in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone USP is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone USP has the molecular formula C22H29FO4 and a molecular weight of 376.46. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>70934-531-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (70934-531-60) </PackageDescription>
<NDC11Code>70934-0531-60</NDC11Code>
<ProductNDC>70934-531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075964</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated. , 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia. .</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadolhydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>71205-531-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71205-531-60) </PackageDescription>
<NDC11Code>71205-0531-60</NDC11Code>
<ProductNDC>71205-531</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hcl</ProprietaryName>
<NonProprietaryName>Fexofenadine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204097</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. § runny nose. § sneezing. § itchy, watery eyes. § itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-531-53</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (71610-531-53) </PackageDescription>
<NDC11Code>71610-0531-53</NDC11Code>
<ProductNDC>71610-531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190808</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040245</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carisoprodol Tablets USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Carisoprodol Tablets USP are available as 350 mg round, white tablets for oral administration. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in Carisoprodol Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>71610-531-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (71610-531-60) </PackageDescription>
<NDC11Code>71610-0531-60</NDC11Code>
<ProductNDC>71610-531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190808</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040245</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carisoprodol Tablets USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Carisoprodol Tablets USP are available as 350 mg round, white tablets for oral administration. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in Carisoprodol Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>76494-531-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (76494-531-06) </PackageDescription>
<NDC11Code>76494-0531-06</NDC11Code>
<ProductNDC>76494-531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078106</ApplicationNumber>
<LabelerName>Prinston Pharmaceutical Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is an antiepileptic drug indicated for adjunctive therapy in the treatment of: 1 Partial onset seizures in patients four years of age and older with epilepsy (1.1), 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 3 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 (pink), 500 mg (pink), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of Levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc, and additional agents listed below. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>68387-100-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68387-100-60)</PackageDescription>
<NDC11Code>68387-0100-60</NDC11Code>
<ProductNDC>68387-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074843</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals 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>
<IndicationAndUsage>Propoxyphene napsylate and acetaminophen tablets, USP are indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Propoxyphene Napsylate, USP is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water and soluble in methanol, ethanol, chloroform, and acetone. Chemically, it is (αS,1R)-α-[2-(Dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-napthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. 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. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula. Propoxyphene Napsylate and Acetaminophen Tablets, USP 50 mg/325 mgEach tablet contains: Propoxyphene Napsylate ............................50 mg (88.4 μmol) Acetaminophen .........................................325 mg (2150 μmol) In addition each tablet contains the following inactive ingredients: carnauba wax, D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide. Propoxyphene Napsylate and Acetaminophen Tablets, USP 100 mg/650 mgEach tablet contains: Propoxyphene Napsylate ...........................100 mg (176.8 μmol) Acetaminophen ..........................................650 mg (4300 μmol)In addition each tablet contains the following inactive ingredients: carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide. The orange tablets also contain D&C Yellow #10 Aluminum Lake and FD&C Red #40 Aluminum Lake. The pink tablets also contain FD&C Red #40 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>68387-108-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (68387-108-60)</PackageDescription>
<NDC11Code>68387-0108-60</NDC11Code>
<ProductNDC>68387-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metaxalone</ProprietaryName>
<NonProprietaryName>Metaxalone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040486</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METAXALONE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metaxalone tablets are indicated as an adjunct to rest, physical therapy and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Metaxalone tablets are available as an 800 mg tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy)methyl]-2-oxazolidinone. The empirical formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is. Metaxalone is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: alginic acid, ammonium calcium alginate, B-Rose Liquid, corn starch and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>68387-140-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (68387-140-60)</PackageDescription>
<NDC11Code>68387-0140-60</NDC11Code>
<ProductNDC>68387-140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076347</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tizanidine hydrochloride is a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Tizanidine hydrochloride is a centrally acting α2-adrenergic agonist. Tizanidine hydrochloride, USP is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine’s molecular formula is C9H8ClN5S·HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine tablets, USP are supplied 4 mg tablets for oral administration. Tizanidine tablets are composed of the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base and 4.576 mg equivalent to 4 mg tizanidine base), and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose, pregelatinized Starch and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>68387-165-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (68387-165-60)</PackageDescription>
<NDC11Code>68387-0165-60</NDC11Code>
<ProductNDC>68387-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072192</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Trazodone hydrochloride tablets are indicated for the treatment of depression. The efficacy of trazodone has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association's Diagnostic and Statistical Manual, III.a. Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least two weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.</IndicationAndUsage>
<Description>Trazodone hydrochloride is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl] propyl]-1,2,4-triazolo[4,3-a]pyridin-3 (2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. It has a structural formula as follows. Each tablet for oral administration contains 50 mg or 100 mg of trazodone hydrochloride. Trazodone hydrochloride tablets 50 mg and 100 mg contain the inactive ingredients hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68387-210-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (68387-210-60)</PackageDescription>
<NDC11Code>68387-0210-60</NDC11Code>
<ProductNDC>68387-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68387-230-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (68387-230-60)</PackageDescription>
<NDC11Code>68387-0230-60</NDC11Code>
<ProductNDC>68387-230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089699</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α- Epoxy-3-methoxy-17-methylmorphinan- 6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4’-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Hydrocodone bitartrate and acetaminophen tablets, USP for oral administration are available in a variety of strength as described in the following table. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, starch, and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68387-235-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (68387-235-60)</PackageDescription>
<NDC11Code>68387-0235-60</NDC11Code>
<ProductNDC>68387-235</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040746</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains. Hydrocodone Bitartrate, USP ......................... 10 mg. Acetaminophen, USP .................................... 325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>68387-250-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (68387-250-60)</PackageDescription>
<NDC11Code>68387-0250-60</NDC11Code>
<ProductNDC>68387-250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089805</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.</IndicationAndUsage>
<Description>Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each 300 mg/30 mg Acetaminophen and Codeine Phosphate Tablet contains: Acetaminophen ......................................................................................................300 mg Codeine Phosphate ..................................................................................................30 mg. Each 300 mg/60 mg Acetaminophen and Codeine Phosphate Tablet contains: Acetaminophen ......................................................................................................300 mg Codeine Phosphate ..................................................................................................60 mg.</Description>
</NDC>
<NDC>
<NDCCode>68387-260-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68387-260-60)</PackageDescription>
<NDC11Code>68387-0260-60</NDC11Code>
<ProductNDC>68387-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077863</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium delayed-release tablets, are indicated: 1 For relief of signs and symptoms of osteoarthritis, 2 For relief of signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets are available as delayed-release tablets of 75 mg for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in Diclofenac sodium delayed-release tablets include: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, opadry brown (Titanium dioxide, hypromellose, polyethylene glycol, iron oxide red, iron oxide yellow) and purified water.</Description>
</NDC>
<NDC>
<NDCCode>68387-310-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68387-310-60)</PackageDescription>
<NDC11Code>68387-0310-60</NDC11Code>
<ProductNDC>68387-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranitidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074467</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ranitidine is indicated in: 1 Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year., 3 The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg two times a day., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
<Description>Ranitidine hydrochloride (HCl), is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The empirical formula is C13H22N4O3S HCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur like odor. Each tablet, for oral administration contains 168 mg or 336 mg of ranitidine hydrochloride equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: D & C Red #30 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, triethyl citrate, sodium starch glycolate, titanium dioxide and flavoring. The 300 mg also contains: D & C Yellow #10 Aluminum Lake. Each capsule, for oral administration contains 168 mg or 336 mg of ranitidine hydrochloride equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: Ammonium hydroxide, colloidal silicon dioxide, corn starch, FD & C Blue #1, FD & C Red #40, FD & C Yellow #6, gelatin, magnesium stearate, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68387-340-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (68387-340-60)</PackageDescription>
<NDC11Code>68387-0340-60</NDC11Code>
<ProductNDC>68387-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085159</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is. The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate.</Description>
</NDC>
<NDC>
<NDCCode>68387-342-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (68387-342-60)</PackageDescription>
<NDC11Code>68387-0342-60</NDC11Code>
<ProductNDC>68387-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085159</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is. The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate.</Description>
</NDC>
<NDC>
<NDCCode>68387-404-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (68387-404-60)</PackageDescription>
<NDC11Code>68387-0404-60</NDC11Code>
<ProductNDC>68387-404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078428</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Postherpetic Neuralgia. Gabapentin Capsules is indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin Capsules is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin Capsules is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.</IndicationAndUsage>
<Description>Gabapentin Capsules are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin. The inactive ingredients for the capsules are magnesium stearate, pregelatinized starch, starch and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No.6 and FD&C Blue No.1. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25.</Description>
</NDC>
<NDC>
<NDCCode>68387-410-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (68387-410-60)</PackageDescription>
<NDC11Code>68387-0410-60</NDC11Code>
<ProductNDC>68387-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078428</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Postherpetic Neuralgia. Gabapentin Capsules is indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin Capsules is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin Capsules is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.</IndicationAndUsage>
<Description>Gabapentin Capsules are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin. The inactive ingredients for the capsules are magnesium stearate, pregelatinized starch, starch and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No.6 and FD&C Blue No.1. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25.</Description>
</NDC>
<NDC>
<NDCCode>68387-497-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (68387-497-60)</PackageDescription>
<NDC11Code>68387-0497-60</NDC11Code>
<ProductNDC>68387-497</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076475</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>37.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, are indicated for the short-term (five days or less) management of acute pain.</IndicationAndUsage>
<Description>Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, combines two analgesics, tramadol and acetaminophen. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are orange in color. Tramadol hydrochloride and acetaminophen tablets are intended for oral administration. Inactive ingredients in the tablet are crospovidone, magnesium stearate, microcrystalline cellulose, OPADRY® II Orange, povidone, pregelatinized starch, purified water, and stearic acid. OPADRY® II Orange contains: FD&C red #40; FD&C yellow #6; hypromellose 2910 3cP, 6cP, and 50cP; polydextrose; polyethylene glycol; titanium dioxide; triacetate; and triacetin.</Description>
</NDC>
</NDCList>