{
"NDC": [
{
"NDCCode": "62802-172-65",
"PackageDescription": "605 g in 1 BOTTLE, PLASTIC (62802-172-65)",
"NDC11Code": "62802-0172-65",
"ProductNDC": "62802-172",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ocean Potion Instant Burn Relief Ice",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Sun & Skin Care Research, LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": ".5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Temporarily Relieves pain and itching due to: 1 sunburn, 2 minor burns."
},
{
"NDCCode": "63824-172-65",
"PackageDescription": "1 BOTTLE in 1 CARTON (63824-172-65) > 148 mL in 1 BOTTLE",
"NDC11Code": "63824-0172-65",
"ProductNDC": "63824-172",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Delsym",
"NonProprietaryName": "Dextromethorphan",
"DosageFormName": "SUSPENSION, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100504",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018658",
"LabelerName": "Reckitt Benckiser LLC",
"SubstanceName": "DEXTROMETHORPHAN",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0597-0425-78",
"PackageDescription": "1 BAG in 1 CARTON (0597-0425-78) / 60 PELLET in 1 BAG",
"NDC11Code": "00597-0425-78",
"ProductNDC": "0597-0425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pradaxa",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214358",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220316",
"SamplePackage": "N",
"IndicationAndUsage": "PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).",
"Description": "PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid."
},
{
"NDCCode": "0597-0430-18",
"PackageDescription": "1 BAG in 1 CARTON (0597-0430-18) / 60 PELLET in 1 BAG",
"NDC11Code": "00597-0430-18",
"ProductNDC": "0597-0430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pradaxa",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214358",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220316",
"SamplePackage": "N",
"IndicationAndUsage": "PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).",
"Description": "PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid."
},
{
"NDCCode": "0597-0435-96",
"PackageDescription": "1 BAG in 1 CARTON (0597-0435-96) / 60 PELLET in 1 BAG",
"NDC11Code": "00597-0435-96",
"ProductNDC": "0597-0435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pradaxa",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214358",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220316",
"SamplePackage": "N",
"IndicationAndUsage": "PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).",
"Description": "PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid."
},
{
"NDCCode": "0597-0440-53",
"PackageDescription": "1 BAG in 1 CARTON (0597-0440-53) / 60 PELLET in 1 BAG",
"NDC11Code": "00597-0440-53",
"ProductNDC": "0597-0440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pradaxa",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214358",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220316",
"SamplePackage": "N",
"IndicationAndUsage": "PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).",
"Description": "PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid."
},
{
"NDCCode": "0597-0445-87",
"PackageDescription": "1 BAG in 1 CARTON (0597-0445-87) / 60 PELLET in 1 BAG",
"NDC11Code": "00597-0445-87",
"ProductNDC": "0597-0445",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pradaxa",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214358",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "110",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220316",
"SamplePackage": "N",
"IndicationAndUsage": "PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).",
"Description": "PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid."
},
{
"NDCCode": "0597-0450-16",
"PackageDescription": "1 BAG in 1 CARTON (0597-0450-16) / 60 PELLET in 1 BAG",
"NDC11Code": "00597-0450-16",
"ProductNDC": "0597-0450",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pradaxa",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214358",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220316",
"SamplePackage": "N",
"IndicationAndUsage": "PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).",
"Description": "PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid."
},
{
"NDCCode": "12634-537-00",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-00)",
"NDC11Code": "12634-0537-00",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-01)",
"NDC11Code": "12634-0537-01",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-55",
"PackageDescription": "15 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-55)",
"NDC11Code": "12634-0537-55",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-60)",
"NDC11Code": "12634-0537-60",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-69",
"PackageDescription": "9 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-69)",
"NDC11Code": "12634-0537-69",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-71",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-71)",
"NDC11Code": "12634-0537-71",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-80",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-80)",
"NDC11Code": "12634-0537-80",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-82",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-82)",
"NDC11Code": "12634-0537-82",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-85",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-85)",
"NDC11Code": "12634-0537-85",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-91",
"PackageDescription": "1 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-91)",
"NDC11Code": "12634-0537-91",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-98",
"PackageDescription": "8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-98)",
"NDC11Code": "12634-0537-98",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "16590-874-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16590-874-30)",
"NDC11Code": "16590-0874-30",
"ProductNDC": "16590-874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darvon-n",
"NonProprietaryName": "Propoxyphene Napsylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090925",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016862",
"LabelerName": "Stat Rx USA",
"SubstanceName": "PROPOXYPHENE NAPSYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Darvon-N is indicated for the relief of mild to moderate pain.",
"Description": "Darvon-N contains propoxyphene napsylate, USP which 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-naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.72. 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. Each tablet of Darvon-N contains 100 mg (176.8 μmol) propoxyphene napsylate. The tablet also contains cellulose, cornstarch, iron oxides, lactose, magnesium stearate, silicon dioxide, stearic acid, and titanium dioxide."
},
{
"NDCCode": "16590-874-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (16590-874-60)",
"NDC11Code": "16590-0874-60",
"ProductNDC": "16590-874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darvon-n",
"NonProprietaryName": "Propoxyphene Napsylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090925",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016862",
"LabelerName": "Stat Rx USA",
"SubstanceName": "PROPOXYPHENE NAPSYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Darvon-N is indicated for the relief of mild to moderate pain.",
"Description": "Darvon-N contains propoxyphene napsylate, USP which 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-naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.72. 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. Each tablet of Darvon-N contains 100 mg (176.8 μmol) propoxyphene napsylate. The tablet also contains cellulose, cornstarch, iron oxides, lactose, magnesium stearate, silicon dioxide, stearic acid, and titanium dioxide."
},
{
"NDCCode": "16590-874-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (16590-874-90)",
"NDC11Code": "16590-0874-90",
"ProductNDC": "16590-874",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darvon-n",
"NonProprietaryName": "Propoxyphene Napsylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090925",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016862",
"LabelerName": "Stat Rx USA",
"SubstanceName": "PROPOXYPHENE NAPSYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Darvon-N is indicated for the relief of mild to moderate pain.",
"Description": "Darvon-N contains propoxyphene napsylate, USP which 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-naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.72. 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. Each tablet of Darvon-N contains 100 mg (176.8 μmol) propoxyphene napsylate. The tablet also contains cellulose, cornstarch, iron oxides, lactose, magnesium stearate, silicon dioxide, stearic acid, and titanium dioxide."
},
{
"NDCCode": "21695-280-08",
"PackageDescription": "8 TABLET, FILM COATED in 1 BOTTLE (21695-280-08)",
"NDC11Code": "21695-0280-08",
"ProductNDC": "21695-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Rebel Distributors Corp.",
"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 are indicated for the relief of mild to moderate pain.",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone."
},
{
"NDCCode": "21695-280-12",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE (21695-280-12)",
"NDC11Code": "21695-0280-12",
"ProductNDC": "21695-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Rebel Distributors Corp.",
"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 are indicated for the relief of mild to moderate pain.",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone."
},
{
"NDCCode": "21695-280-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (21695-280-15)",
"NDC11Code": "21695-0280-15",
"ProductNDC": "21695-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Rebel Distributors Corp.",
"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 are indicated for the relief of mild to moderate pain.",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone."
},
{
"NDCCode": "21695-280-16",
"PackageDescription": "16 TABLET, FILM COATED in 1 BOTTLE (21695-280-16)",
"NDC11Code": "21695-0280-16",
"ProductNDC": "21695-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Rebel Distributors Corp.",
"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 are indicated for the relief of mild to moderate pain.",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone."
},
{
"NDCCode": "21695-280-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (21695-280-20)",
"NDC11Code": "21695-0280-20",
"ProductNDC": "21695-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Rebel Distributors Corp.",
"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 are indicated for the relief of mild to moderate pain.",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone."
},
{
"NDCCode": "21695-280-28",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (21695-280-28)",
"NDC11Code": "21695-0280-28",
"ProductNDC": "21695-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Rebel Distributors Corp.",
"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 are indicated for the relief of mild to moderate pain.",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone."
},
{
"NDCCode": "21695-280-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (21695-280-30)",
"NDC11Code": "21695-0280-30",
"ProductNDC": "21695-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Rebel Distributors Corp.",
"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 are indicated for the relief of mild to moderate pain.",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone."
},
{
"NDCCode": "21695-280-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (21695-280-60)",
"NDC11Code": "21695-0280-60",
"ProductNDC": "21695-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Rebel Distributors Corp.",
"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 are indicated for the relief of mild to moderate pain.",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>62802-172-65</NDCCode>
<PackageDescription>605 g in 1 BOTTLE, PLASTIC (62802-172-65)</PackageDescription>
<NDC11Code>62802-0172-65</NDC11Code>
<ProductNDC>62802-172</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ocean Potion Instant Burn Relief Ice</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Sun & Skin Care Research, LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily Relieves pain and itching due to: 1 sunburn, 2 minor burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63824-172-65</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (63824-172-65) > 148 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63824-0172-65</NDC11Code>
<ProductNDC>63824-172</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Delsym</ProprietaryName>
<NonProprietaryName>Dextromethorphan</NonProprietaryName>
<DosageFormName>SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100504</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018658</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0597-0425-78</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (0597-0425-78) / 60 PELLET in 1 BAG</PackageDescription>
<NDC11Code>00597-0425-78</NDC11Code>
<ProductNDC>0597-0425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pradaxa</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214358</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).</IndicationAndUsage>
<Description>PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid.</Description>
</NDC>
<NDC>
<NDCCode>0597-0430-18</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (0597-0430-18) / 60 PELLET in 1 BAG</PackageDescription>
<NDC11Code>00597-0430-18</NDC11Code>
<ProductNDC>0597-0430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pradaxa</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214358</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).</IndicationAndUsage>
<Description>PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid.</Description>
</NDC>
<NDC>
<NDCCode>0597-0435-96</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (0597-0435-96) / 60 PELLET in 1 BAG</PackageDescription>
<NDC11Code>00597-0435-96</NDC11Code>
<ProductNDC>0597-0435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pradaxa</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214358</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).</IndicationAndUsage>
<Description>PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid.</Description>
</NDC>
<NDC>
<NDCCode>0597-0440-53</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (0597-0440-53) / 60 PELLET in 1 BAG</PackageDescription>
<NDC11Code>00597-0440-53</NDC11Code>
<ProductNDC>0597-0440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pradaxa</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214358</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).</IndicationAndUsage>
<Description>PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid.</Description>
</NDC>
<NDC>
<NDCCode>0597-0445-87</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (0597-0445-87) / 60 PELLET in 1 BAG</PackageDescription>
<NDC11Code>00597-0445-87</NDC11Code>
<ProductNDC>0597-0445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pradaxa</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214358</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>110</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).</IndicationAndUsage>
<Description>PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid.</Description>
</NDC>
<NDC>
<NDCCode>0597-0450-16</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (0597-0450-16) / 60 PELLET in 1 BAG</PackageDescription>
<NDC11Code>00597-0450-16</NDC11Code>
<ProductNDC>0597-0450</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pradaxa</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220316</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214358</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).</IndicationAndUsage>
<Description>PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-00</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-00)</PackageDescription>
<NDC11Code>12634-0537-00</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-01)</PackageDescription>
<NDC11Code>12634-0537-01</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-55</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-55)</PackageDescription>
<NDC11Code>12634-0537-55</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-60)</PackageDescription>
<NDC11Code>12634-0537-60</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-69</NDCCode>
<PackageDescription>9 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-69)</PackageDescription>
<NDC11Code>12634-0537-69</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-71</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-71)</PackageDescription>
<NDC11Code>12634-0537-71</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-80</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-80)</PackageDescription>
<NDC11Code>12634-0537-80</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-82</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-82)</PackageDescription>
<NDC11Code>12634-0537-82</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-85</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-85)</PackageDescription>
<NDC11Code>12634-0537-85</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-91</NDCCode>
<PackageDescription>1 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-91)</PackageDescription>
<NDC11Code>12634-0537-91</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-98</NDCCode>
<PackageDescription>8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-98)</PackageDescription>
<NDC11Code>12634-0537-98</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>16590-874-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16590-874-30)</PackageDescription>
<NDC11Code>16590-0874-30</NDC11Code>
<ProductNDC>16590-874</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darvon-n</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090925</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016862</ApplicationNumber>
<LabelerName>Stat Rx USA</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Darvon-N is indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Darvon-N contains propoxyphene napsylate, USP which 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-naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.72. 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. Each tablet of Darvon-N contains 100 mg (176.8 μmol) propoxyphene napsylate. The tablet also contains cellulose, cornstarch, iron oxides, lactose, magnesium stearate, silicon dioxide, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16590-874-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16590-874-60)</PackageDescription>
<NDC11Code>16590-0874-60</NDC11Code>
<ProductNDC>16590-874</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darvon-n</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090925</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016862</ApplicationNumber>
<LabelerName>Stat Rx USA</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Darvon-N is indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Darvon-N contains propoxyphene napsylate, USP which 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-naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.72. 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. Each tablet of Darvon-N contains 100 mg (176.8 μmol) propoxyphene napsylate. The tablet also contains cellulose, cornstarch, iron oxides, lactose, magnesium stearate, silicon dioxide, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16590-874-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (16590-874-90)</PackageDescription>
<NDC11Code>16590-0874-90</NDC11Code>
<ProductNDC>16590-874</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darvon-n</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090925</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016862</ApplicationNumber>
<LabelerName>Stat Rx USA</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Darvon-N is indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Darvon-N contains propoxyphene napsylate, USP which 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-naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.72. 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. Each tablet of Darvon-N contains 100 mg (176.8 μmol) propoxyphene napsylate. The tablet also contains cellulose, cornstarch, iron oxides, lactose, magnesium stearate, silicon dioxide, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-280-08</NDCCode>
<PackageDescription>8 TABLET, FILM COATED in 1 BOTTLE (21695-280-08)</PackageDescription>
<NDC11Code>21695-0280-08</NDC11Code>
<ProductNDC>21695-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</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 are indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>21695-280-12</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE (21695-280-12)</PackageDescription>
<NDC11Code>21695-0280-12</NDC11Code>
<ProductNDC>21695-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</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 are indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>21695-280-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE (21695-280-15)</PackageDescription>
<NDC11Code>21695-0280-15</NDC11Code>
<ProductNDC>21695-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</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 are indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>21695-280-16</NDCCode>
<PackageDescription>16 TABLET, FILM COATED in 1 BOTTLE (21695-280-16)</PackageDescription>
<NDC11Code>21695-0280-16</NDC11Code>
<ProductNDC>21695-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</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 are indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>21695-280-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (21695-280-20)</PackageDescription>
<NDC11Code>21695-0280-20</NDC11Code>
<ProductNDC>21695-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</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 are indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>21695-280-28</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (21695-280-28)</PackageDescription>
<NDC11Code>21695-0280-28</NDC11Code>
<ProductNDC>21695-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</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 are indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>21695-280-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (21695-280-30)</PackageDescription>
<NDC11Code>21695-0280-30</NDC11Code>
<ProductNDC>21695-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</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 are indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>21695-280-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (21695-280-60)</PackageDescription>
<NDC11Code>21695-0280-60</NDC11Code>
<ProductNDC>21695-280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</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 are indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink or white tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C red No. 27 aluminum lake, D&C yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone.</Description>
</NDC>
</NDCList>