{
"NDC": [
{
"NDCCode": "67046-141-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-141-60)",
"NDC11Code": "67046-0141-60",
"ProductNDC": "67046-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090554",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "67046-141-07",
"PackageDescription": "7 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-141-07)",
"NDC11Code": "67046-0141-07",
"ProductNDC": "67046-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090554",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "67046-141-14",
"PackageDescription": "14 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-141-14)",
"NDC11Code": "67046-0141-14",
"ProductNDC": "67046-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090554",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "67046-141-15",
"PackageDescription": "15 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-141-15)",
"NDC11Code": "67046-0141-15",
"ProductNDC": "67046-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090554",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "67046-141-20",
"PackageDescription": "20 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-141-20)",
"NDC11Code": "67046-0141-20",
"ProductNDC": "67046-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090554",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "67046-141-21",
"PackageDescription": "21 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-141-21)",
"NDC11Code": "67046-0141-21",
"ProductNDC": "67046-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090554",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "67046-141-28",
"PackageDescription": "28 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-141-28)",
"NDC11Code": "67046-0141-28",
"ProductNDC": "67046-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090554",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "67046-141-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-141-30)",
"NDC11Code": "67046-0141-30",
"ProductNDC": "67046-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090554",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "21695-141-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BLISTER PACK (21695-141-60)",
"NDC11Code": "21695-0141-60",
"ProductNDC": "21695-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089684",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.",
"Description": "Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C21H26CIN3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: lactose (monohydrate), hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), titanium dioxide, and polysorbate 80. Its structural formula is."
},
{
"NDCCode": "23155-141-06",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-141-06) ",
"NDC11Code": "23155-0141-06",
"ProductNDC": "23155-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"ProprietaryNameSuffix": "Delayed Release",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200856",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130430",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections (1.1) Sexually transmitted infections (1.2) Respiratory tract infections (1.3) Specific bacterial infections (1.4) Ophthalmic infections (1.5) Anthrax, including inhalational anthrax (post-exposure) (1.6) Alternative treatment for selected infections when penicillin is contraindicated (1.7) Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) Prophylaxis of malaria (1.9). UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10).",
"Description": "Doxycycline hyclate delayed-release tablets, USP, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 75 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 86.6 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate, microcrystalline cellulose; sodium lauryl sulfate, sodium chloride, hypromellose phthalate, hypromellose, triethyl citrate, anhydrous lactose, crospovidone, stearic acid, magnesium stearate. The tablets also contain opadry 03K29121 clear, which contains: hypromellose and triacetin. Each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.8 mg (0.208 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6.4 mg (0.278 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9.6 mg (0.417 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12.8 mg (0.556 mEq) of sodium. USP dissolution test pending."
},
{
"NDCCode": "30142-141-72",
"PackageDescription": "1 BOTTLE in 1 CARTON (30142-141-72) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "30142-0141-72",
"ProductNDC": "30142-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heartburn Prevention",
"ProprietaryNameSuffix": "Original Strength",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075400",
"LabelerName": "Kroger Company",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-11-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "34666-141-60",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (34666-141-60) > 60 TABLET in 1 BLISTER PACK",
"NDC11Code": "34666-0141-60",
"ProductNDC": "34666-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flu-less",
"NonProprietaryName": "Aconitum Napellus, Dulcamara, Gelsemium Sempervirens",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120910",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NARTEX LABORATORIOS HOMEOPATICOS SA DE CV",
"SubstanceName": "ACONITUM NAPELLUS; SOLANUM DULCAMARA FLOWER; GELSEMIUM SEMPERVIRENS ROOT",
"StrengthNumber": "6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2018-05-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "36800-141-72",
"PackageDescription": "1 BOTTLE in 1 CARTON (36800-141-72) / 60 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "36800-0141-72",
"ProductNDC": "36800-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Acid Reducer",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075400",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090911",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "37808-141-72",
"PackageDescription": "1 BOTTLE in 1 CARTON (37808-141-72) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "37808-0141-72",
"ProductNDC": "37808-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heartburn Prevention",
"ProprietaryNameSuffix": "Acid Reducer",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075400",
"LabelerName": "H E B",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-10-25",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "41250-141-72",
"PackageDescription": "1 BOTTLE in 1 CARTON (41250-141-72) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "41250-0141-72",
"ProductNDC": "41250-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acid Reducer",
"ProprietaryNameSuffix": "Original Strength",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091014",
"EndMarketingDate": "20210331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075400",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20091014",
"EndMarketingDatePackage": "20210331",
"SamplePackage": "N"
},
{
"NDCCode": "41520-141-72",
"PackageDescription": "1 BOTTLE in 1 CARTON (41520-141-72) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "41520-0141-72",
"ProductNDC": "41520-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Care One Acid Reducer",
"ProprietaryNameSuffix": "Original Strength",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075400",
"LabelerName": "American Sales Company",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-10-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "42507-141-72",
"PackageDescription": "1 BOTTLE in 1 CARTON (42507-141-72) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "42507-0141-72",
"ProductNDC": "42507-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acid Reducer",
"ProprietaryNameSuffix": "Original Strength",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091019",
"EndMarketingDate": "20190122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075400",
"LabelerName": "HyVee Inc",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20091019",
"EndMarketingDatePackage": "20190122",
"SamplePackage": "N"
},
{
"NDCCode": "43353-141-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (43353-141-60)",
"NDC11Code": "43353-0141-60",
"ProductNDC": "43353-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Dinitrate",
"NonProprietaryName": "Isosorbide Dinitrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087537",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ISOSORBIDE DINITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide dinitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name for isosorbide dinitrate is 1,4:3,6-dianhydro-D-glucitol 2, 5-dinitrate. The compound has the following structural formula. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate tablets are available for oral administration as 5 mg, 10 mg, 20 mg, or 30 mg tablets. Each tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid. In addition, the 20 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6; the 30 mg tablet contains FD&C Blue #1."
},
{
"NDCCode": "53489-141-06",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-06) ",
"NDC11Code": "53489-0141-06",
"ProductNDC": "53489-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinidine Gluconate",
"NonProprietaryName": "Quinidine Gluconate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19870210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089338",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "QUINIDINE GLUCONATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2018-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19870210",
"SamplePackage": "N",
"IndicationAndUsage": "Conversion of atrial fibrillation/flutter. In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine gluconate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine gluconate should be discontinued.",
"Description": "Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with Class Ia activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine gluconate is the gluconate salt of quinidine; its chemical name is cinchonan-9-ol, 6'-methoxy-, (9S)-, mono-D-gluconate; its structural formula is. Its empirical formula is C20H24N2O2 C6H12O7, and its molecular weight is 520.58, of which 62.3% is quinidine base. Each quinidine gluconate extended-release tablet contains 324 mg of quinidine gluconate (202 mg of quinidine base) in a matrix to provide extended-release; the inactive ingredients include corn starch, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, and sodium alginate. This product complies with USP Drug Release Test 5."
},
{
"NDCCode": "55910-141-60",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (55910-141-60) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55910-0141-60",
"ProductNDC": "55910-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dg Health Heartburn Prevention",
"ProprietaryNameSuffix": "Original Strength",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075400",
"LabelerName": "Dolgencorp, LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100310",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "55910-141-72",
"PackageDescription": "1 BOTTLE in 1 CARTON (55910-141-72) / 60 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "55910-0141-72",
"ProductNDC": "55910-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dg Health Heartburn Prevention",
"ProprietaryNameSuffix": "Original Strength",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075400",
"LabelerName": "Dolgencorp, LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200122",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "59779-141-60",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (59779-141-60) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "59779-0141-60",
"ProductNDC": "59779-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acid Controller",
"ProprietaryNameSuffix": "Original Strength",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075400",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20091203",
"SamplePackage": "N"
},
{
"NDCCode": "59779-141-72",
"PackageDescription": "1 BOTTLE in 1 CARTON (59779-141-72) > 60 TABLET in 1 BOTTLE",
"NDC11Code": "59779-0141-72",
"ProductNDC": "59779-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acid Controller",
"ProprietaryNameSuffix": "Original Strength",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075400",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20100219",
"SamplePackage": "N"
},
{
"NDCCode": "60760-141-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (60760-141-60) ",
"NDC11Code": "60760-0141-60",
"ProductNDC": "60760-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130509",
"EndMarketingDate": "20180531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075795",
"LabelerName": "St Marys Medical Park Pharmacy",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130509",
"EndMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "61442-141-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (61442-141-60) ",
"NDC11Code": "61442-0141-60",
"ProductNDC": "61442-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075991",
"LabelerName": "Carlsbad Technology, Inc.",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20021125",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.",
"Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1 S -[1α( R *), 3α, 7β, 8β(2 S *,4 S *),8aβ]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C 24 H 36 O 5 and its molecular weight is 404.55. Its structural formula is:. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, pregelatinized starch, sodium starch glycolate, butylated hydroxyanisole and talc. Butylated hydroxyanisole (BHA) is added as a preservative."
},
{
"NDCCode": "62332-141-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (62332-141-60) ",
"NDC11Code": "62332-0141-60",
"ProductNDC": "62332-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204519",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151201",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is indicated.",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white or almost white crystalline powder with a pKa of about 11 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and soluble to freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains propylene glycol, red iron oxide and shellac. 100 mg capsule contains FD & C Blue No. # 2 aluminum lake, propylene glycol and shellac. 200 mg capsule contains propylene glycol, shellac and yellow iron oxide. 400 mg capsule contains FD & C Blue No. # 2 aluminum lake, propylene glycol, shellac, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "63187-141-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (63187-141-60) ",
"NDC11Code": "63187-0141-60",
"ProductNDC": "63187-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2022-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220607",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "64980-141-06",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-141-06)",
"NDC11Code": "64980-0141-06",
"ProductNDC": "64980-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam Extended-release",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077996",
"LabelerName": "Rising Pharmaceuticals Inc",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "67777-141-60",
"PackageDescription": "3790 mL in 1 BOTTLE (67777-141-60) ",
"NDC11Code": "67777-0141-60",
"ProductNDC": "67777-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dynarex Povidone Iodine Prep Solution",
"NonProprietaryName": "Povidone Iodine Prep Solution",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180508",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Dynarex Corporation",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180508",
"SamplePackage": "N"
},
{
"NDCCode": "67777-141-61",
"PackageDescription": "4 BOTTLE in 1 CASE (67777-141-61) / 3790 mL in 1 BOTTLE (67777-141-60) ",
"NDC11Code": "67777-0141-61",
"ProductNDC": "67777-141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dynarex Povidone Iodine Prep Solution",
"NonProprietaryName": "Povidone Iodine Prep Solution",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180508",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Dynarex Corporation",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180508",
"SamplePackage": "N",
"IndicationAndUsage": "For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection."
}
]
}
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<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide.</Description>
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<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-141-14</NDCCode>
<PackageDescription>14 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-141-14)</PackageDescription>
<NDC11Code>67046-0141-14</NDC11Code>
<ProductNDC>67046-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090554</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide.</Description>
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<NDC>
<NDCCode>67046-141-15</NDCCode>
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<RouteName>ORAL</RouteName>
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<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-141-20</NDCCode>
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<NDC11Code>67046-0141-20</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
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<ApplicationNumber>ANDA090554</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide.</Description>
</NDC>
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<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-141-28</NDCCode>
<PackageDescription>28 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-141-28)</PackageDescription>
<NDC11Code>67046-0141-28</NDC11Code>
<ProductNDC>67046-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090554</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-141-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-141-30)</PackageDescription>
<NDC11Code>67046-0141-30</NDC11Code>
<ProductNDC>67046-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090554</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone (Kollidon 30), hydroxypropyl cellulose low substituted, talc, methylene chloride, methacrylic acid: ethyl acrylate copolymer (1:1), and diethyl phthalate. In addition, 125 mg tablets are coated with opadry clear 04K59023 and opadry II complete film coating system 86G540000 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II complete film coating system 86G540000 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, FD&C Red #40, lecithin (soya), and vanillin. 250 mg tablets are coated with opadry clear 04K59023 and opadry II 86G53866 orange. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G53866 orange contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), vanillin, FD&C Yellow #6, and iron oxide yellow. 500 mg tablets are coated with opadry clear 04K59023 and opadry II 86G84795 pink. Opadry clear 04K59023 contains hypromellose and triacetin, opadry II 86G84795 pink contains polyvinyl alcohol, talc, titanium dioxide, macrogol/PEG 3350, lecithin (soya), FD&C Red #40, vanillin, and FD&C Blue #2. The tablets are printed with opacode black S-1-17823 containing shellac glaze in ethanol, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-141-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BLISTER PACK (21695-141-60)</PackageDescription>
<NDC11Code>21695-0141-60</NDC11Code>
<ProductNDC>21695-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089684</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C21H26CIN3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: lactose (monohydrate), hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), titanium dioxide, and polysorbate 80. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>23155-141-06</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-141-06) </PackageDescription>
<NDC11Code>23155-0141-06</NDC11Code>
<ProductNDC>23155-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200856</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections (1.1) Sexually transmitted infections (1.2) Respiratory tract infections (1.3) Specific bacterial infections (1.4) Ophthalmic infections (1.5) Anthrax, including inhalational anthrax (post-exposure) (1.6) Alternative treatment for selected infections when penicillin is contraindicated (1.7) Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) Prophylaxis of malaria (1.9). UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10).</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, USP, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 75 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 86.6 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate, microcrystalline cellulose; sodium lauryl sulfate, sodium chloride, hypromellose phthalate, hypromellose, triethyl citrate, anhydrous lactose, crospovidone, stearic acid, magnesium stearate. The tablets also contain opadry 03K29121 clear, which contains: hypromellose and triacetin. Each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.8 mg (0.208 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6.4 mg (0.278 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9.6 mg (0.417 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12.8 mg (0.556 mEq) of sodium. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>30142-141-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30142-141-72) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0141-72</NDC11Code>
<ProductNDC>30142-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heartburn Prevention</ProprietaryName>
<ProprietaryNameSuffix>Original Strength</ProprietaryNameSuffix>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075400</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>34666-141-60</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (34666-141-60) > 60 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>34666-0141-60</NDC11Code>
<ProductNDC>34666-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flu-less</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Dulcamara, Gelsemium Sempervirens</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120910</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NARTEX LABORATORIOS HOMEOPATICOS SA DE CV</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; SOLANUM DULCAMARA FLOWER; GELSEMIUM SEMPERVIRENS ROOT</SubstanceName>
<StrengthNumber>6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-05-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>36800-141-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (36800-141-72) / 60 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>36800-0141-72</NDC11Code>
<ProductNDC>36800-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Acid Reducer</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075400</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37808-141-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (37808-141-72) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>37808-0141-72</NDC11Code>
<ProductNDC>37808-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heartburn Prevention</ProprietaryName>
<ProprietaryNameSuffix>Acid Reducer</ProprietaryNameSuffix>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075400</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-10-25</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>41250-141-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41250-141-72) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>41250-0141-72</NDC11Code>
<ProductNDC>41250-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acid Reducer</ProprietaryName>
<ProprietaryNameSuffix>Original Strength</ProprietaryNameSuffix>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091014</StartMarketingDate>
<EndMarketingDate>20210331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075400</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20091014</StartMarketingDatePackage>
<EndMarketingDatePackage>20210331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41520-141-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41520-141-72) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>41520-0141-72</NDC11Code>
<ProductNDC>41520-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Care One Acid Reducer</ProprietaryName>
<ProprietaryNameSuffix>Original Strength</ProprietaryNameSuffix>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075400</ApplicationNumber>
<LabelerName>American Sales Company</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-10-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42507-141-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (42507-141-72) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>42507-0141-72</NDC11Code>
<ProductNDC>42507-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acid Reducer</ProprietaryName>
<ProprietaryNameSuffix>Original Strength</ProprietaryNameSuffix>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091019</StartMarketingDate>
<EndMarketingDate>20190122</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075400</ApplicationNumber>
<LabelerName>HyVee Inc</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20091019</StartMarketingDatePackage>
<EndMarketingDatePackage>20190122</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43353-141-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (43353-141-60)</PackageDescription>
<NDC11Code>43353-0141-60</NDC11Code>
<ProductNDC>43353-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Dinitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Dinitrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087537</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ISOSORBIDE DINITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide dinitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name for isosorbide dinitrate is 1,4:3,6-dianhydro-D-glucitol 2, 5-dinitrate. The compound has the following structural formula. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate tablets are available for oral administration as 5 mg, 10 mg, 20 mg, or 30 mg tablets. Each tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid. In addition, the 20 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6; the 30 mg tablet contains FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>53489-141-06</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-06) </PackageDescription>
<NDC11Code>53489-0141-06</NDC11Code>
<ProductNDC>53489-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinidine Gluconate</ProprietaryName>
<NonProprietaryName>Quinidine Gluconate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089338</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>QUINIDINE GLUCONATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Conversion of atrial fibrillation/flutter. In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine gluconate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine gluconate should be discontinued.</IndicationAndUsage>
<Description>Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with Class Ia activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine gluconate is the gluconate salt of quinidine; its chemical name is cinchonan-9-ol, 6'-methoxy-, (9S)-, mono-D-gluconate; its structural formula is. Its empirical formula is C20H24N2O2 C6H12O7, and its molecular weight is 520.58, of which 62.3% is quinidine base. Each quinidine gluconate extended-release tablet contains 324 mg of quinidine gluconate (202 mg of quinidine base) in a matrix to provide extended-release; the inactive ingredients include corn starch, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, and sodium alginate. This product complies with USP Drug Release Test 5.</Description>
</NDC>
<NDC>
<NDCCode>55910-141-60</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 CARTON (55910-141-60) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55910-0141-60</NDC11Code>
<ProductNDC>55910-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dg Health Heartburn Prevention</ProprietaryName>
<ProprietaryNameSuffix>Original Strength</ProprietaryNameSuffix>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075400</ApplicationNumber>
<LabelerName>Dolgencorp, LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55910-141-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55910-141-72) / 60 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>55910-0141-72</NDC11Code>
<ProductNDC>55910-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dg Health Heartburn Prevention</ProprietaryName>
<ProprietaryNameSuffix>Original Strength</ProprietaryNameSuffix>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075400</ApplicationNumber>
<LabelerName>Dolgencorp, LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59779-141-60</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (59779-141-60) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59779-0141-60</NDC11Code>
<ProductNDC>59779-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acid Controller</ProprietaryName>
<ProprietaryNameSuffix>Original Strength</ProprietaryNameSuffix>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075400</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59779-141-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59779-141-72) > 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>59779-0141-72</NDC11Code>
<ProductNDC>59779-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acid Controller</ProprietaryName>
<ProprietaryNameSuffix>Original Strength</ProprietaryNameSuffix>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075400</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60760-141-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (60760-141-60) </PackageDescription>
<NDC11Code>60760-0141-60</NDC11Code>
<ProductNDC>60760-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130509</StartMarketingDate>
<EndMarketingDate>20180531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075795</ApplicationNumber>
<LabelerName>St Marys Medical Park Pharmacy</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130509</StartMarketingDatePackage>
<EndMarketingDatePackage>20180531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61442-141-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (61442-141-60) </PackageDescription>
<NDC11Code>61442-0141-60</NDC11Code>
<ProductNDC>61442-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075991</ApplicationNumber>
<LabelerName>Carlsbad Technology, Inc.</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.</IndicationAndUsage>
<Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1 S -[1α( R *), 3α, 7β, 8β(2 S *,4 S *),8aβ]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C 24 H 36 O 5 and its molecular weight is 404.55. Its structural formula is:. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, pregelatinized starch, sodium starch glycolate, butylated hydroxyanisole and talc. Butylated hydroxyanisole (BHA) is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>62332-141-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (62332-141-60) </PackageDescription>
<NDC11Code>62332-0141-60</NDC11Code>
<ProductNDC>62332-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204519</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white or almost white crystalline powder with a pKa of about 11 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and soluble to freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains propylene glycol, red iron oxide and shellac. 100 mg capsule contains FD & C Blue No. # 2 aluminum lake, propylene glycol and shellac. 200 mg capsule contains propylene glycol, shellac and yellow iron oxide. 400 mg capsule contains FD & C Blue No. # 2 aluminum lake, propylene glycol, shellac, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>63187-141-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (63187-141-60) </PackageDescription>
<NDC11Code>63187-0141-60</NDC11Code>
<ProductNDC>63187-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>64980-141-06</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64980-141-06)</PackageDescription>
<NDC11Code>64980-0141-06</NDC11Code>
<ProductNDC>64980-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam Extended-release</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077996</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals Inc</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>67777-141-60</NDCCode>
<PackageDescription>3790 mL in 1 BOTTLE (67777-141-60) </PackageDescription>
<NDC11Code>67777-0141-60</NDC11Code>
<ProductNDC>67777-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dynarex Povidone Iodine Prep Solution</ProprietaryName>
<NonProprietaryName>Povidone Iodine Prep Solution</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180508</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Dynarex Corporation</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67777-141-61</NDCCode>
<PackageDescription>4 BOTTLE in 1 CASE (67777-141-61) / 3790 mL in 1 BOTTLE (67777-141-60) </PackageDescription>
<NDC11Code>67777-0141-61</NDC11Code>
<ProductNDC>67777-141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dynarex Povidone Iodine Prep Solution</ProprietaryName>
<NonProprietaryName>Povidone Iodine Prep Solution</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180508</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Dynarex Corporation</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.</IndicationAndUsage>
</NDC>
</NDCList>