{
"NDC": [
{
"NDCCode": "65862-402-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65862-402-10) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "65862-0402-10",
"ProductNDC": "65862-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090554",
"LabelerName": "Aurobindo Pharma Limited",
"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": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141024",
"SamplePackage": "N",
"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, methacrylic acid and ethyl acrylate copolymer dispersion, 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": "65862-402-01",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-01) ",
"NDC11Code": "65862-0402-01",
"ProductNDC": "65862-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090554",
"LabelerName": "Aurobindo Pharma Limited",
"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": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141024",
"SamplePackage": "N",
"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, methacrylic acid and ethyl acrylate copolymer dispersion, 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": "65862-402-05",
"PackageDescription": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-05) ",
"NDC11Code": "65862-0402-05",
"ProductNDC": "65862-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090554",
"LabelerName": "Aurobindo Pharma Limited",
"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": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141024",
"SamplePackage": "N",
"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, methacrylic acid and ethyl acrylate copolymer dispersion, 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": "65862-402-39",
"PackageDescription": "3000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-39) ",
"NDC11Code": "65862-0402-39",
"ProductNDC": "65862-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090554",
"LabelerName": "Aurobindo Pharma Limited",
"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": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141024",
"SamplePackage": "N",
"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, methacrylic acid and ethyl acrylate copolymer dispersion, 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": "65862-402-99",
"PackageDescription": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-402-99) ",
"NDC11Code": "65862-0402-99",
"ProductNDC": "65862-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090554",
"LabelerName": "Aurobindo Pharma Limited",
"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": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141024",
"SamplePackage": "N",
"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, methacrylic acid and ethyl acrylate copolymer dispersion, 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": "16571-402-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (16571-402-10) ",
"NDC11Code": "16571-0402-10",
"ProductNDC": "16571-402",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077829",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091001",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "25021-402-10",
"PackageDescription": "25 VIAL in 1 CARTON (25021-402-10) / 10 mL in 1 VIAL",
"NDC11Code": "25021-0402-10",
"ProductNDC": "25021-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20100706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090808",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "5000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100706",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease , 3 Atrial fibrillation with embolization , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation) , 5 Prevention of clotting in arterial and cardiac surgery , 6 Prophylaxis and treatment of peripheral arterial embolism , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures .",
"Description": "Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated, O-sulfated, or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucuronic acid). Structure of heparin sodium (representative subunits):. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations per mL:. pH 5.0 to 7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment."
},
{
"NDCCode": "33342-402-10",
"PackageDescription": "90 TABLET in 1 BOTTLE (33342-402-10) ",
"NDC11Code": "33342-0402-10",
"ProductNDC": "33342-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211417",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "175",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221221",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown: Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each Levothyroxine sodium tablets, USP contains the inactive ingredients croscarmellose sodium, microcrystalline cellulose, silicon dioxide and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Table 9: Levothyroxine Sodium Tablet Color Additives. * Note - FD&C Yellow No. 6 is orange in color. Levothyroxine Sodium Tablet, USP meets USP Dissolution Test 2."
},
{
"NDCCode": "35418-402-10",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (35418-402-10) ",
"NDC11Code": "35418-0402-10",
"ProductNDC": "35418-402",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Alcohol",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100708",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Zee Medical",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2017-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100708",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "37000-402-01",
"PackageDescription": "1 KIT in 1 PACKAGE (37000-402-01) * 473 mL in 1 BOTTLE, PLASTIC (37000-032-04) * 8 CELLO PACK in 1 CARTON (37000-477-10) > 6 TABLET in 1 CELLO PACK",
"NDC11Code": "37000-0402-01",
"ProductNDC": "37000-402",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pepto-bismol",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "KIT",
"StartMarketingDate": "20110912",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"Status": "Deprecated",
"LastUpdate": "2022-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110912",
"SamplePackage": "N"
},
{
"NDCCode": "42998-402-05",
"PackageDescription": "10 AMPULE in 1 CARTON (42998-402-05) > 5 mL in 1 AMPULE",
"NDC11Code": "42998-0402-05",
"ProductNDC": "42998-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isuprel",
"NonProprietaryName": "Isoproterenol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20131201",
"EndMarketingDate": "20160831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA010515",
"LabelerName": "Marathon Pharmaceuticals, LLC",
"SubstanceName": "ISOPROTERENOL HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "43547-402-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (43547-402-10) ",
"NDC11Code": "43547-0402-10",
"ProductNDC": "43547-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076796",
"LabelerName": "Solco Healthcare LLC",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040326",
"SamplePackage": "N",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20 mg, 40 mg and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1."
},
{
"NDCCode": "49643-402-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49643-402-10) ",
"NDC11Code": "49643-0402-10",
"ProductNDC": "49643-402",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "White Oak Pollen",
"NonProprietaryName": "Quercus Alba",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "QUERCUS ALBA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "50458-402-02",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (50458-402-02) > 10 mL in 1 VIAL, SINGLE-USE (50458-402-01)",
"NDC11Code": "50458-0402-02",
"ProductNDC": "50458-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doribax",
"NonProprietaryName": "Doripenem",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20101015",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022106",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "DORIPENEM",
"StrengthNumber": "250",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-01-09"
},
{
"NDCCode": "51206-402-01",
"PackageDescription": "10 TRAY in 1 BOX (51206-402-01) > 1.87 mL in 1 TRAY",
"NDC11Code": "51206-0402-01",
"ProductNDC": "51206-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flor-opal Sustained-release Fluoride",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL",
"RouteName": "DENTAL",
"StartMarketingDate": "20050301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Ultradent Products, Inc",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2014-12-12"
},
{
"NDCCode": "52958-402-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (52958-402-01) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "52958-0402-01",
"ProductNDC": "52958-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eptifibatide",
"NonProprietaryName": "Eptifibatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210907",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213081",
"LabelerName": "Hainan Shuangcheng Pharmaceuticals Co., Ltd.",
"SubstanceName": "EPTIFIBATIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210907",
"SamplePackage": "N",
"IndicationAndUsage": "Eptifibatide injection is a platelet aggregation inhibitor indicated for: 1 Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) (1.1), 2 Treatment of patients undergoing PCI (including intracoronary stenting) (1.2).",
"Description": "Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N6-(aminoiminomethyl)-N2-(3-mercapto-1-oxopropyl)-L-lysylglycyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1→6)-disulfide. Eptifibatide binds to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets and inhibits platelet aggregation. The eptifibatide peptide is produced by solid-phase peptide synthesis, and is purified by preparative reverse-phase liquid chromatography and lyophilized. The structural formula is. Eptifibatide Injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous (IV) use with an empirical formula of C35H49N11O9S2 and a molecular weight of 831.96. Each 10-mL vial contains 2 mg/mL of eptifibatide and each 100-mL vial contains 0.75 mg/mL of eptifibatide. Each vial of either size also contains 5.25 mg/mL citric acid and sodium hydroxide to adjust the pH to 5.35."
},
{
"NDCCode": "53799-402-11",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (53799-402-11) > 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "53799-0402-11",
"ProductNDC": "53799-402",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pink Eye",
"NonProprietaryName": "Atropa Belladonna, Euphrasia Stricta, Calcium Sulfide",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20190215",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Similasan AG",
"SubstanceName": "ATROPA BELLADONNA; CALCIUM SULFIDE; EUPHRASIA STRICTA",
"StrengthNumber": "6; 12; 6",
"StrengthUnit": "[hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190215",
"SamplePackage": "N",
"IndicationAndUsage": "According to homeopathic principles, the active ingredients in this product temporarily relieve minor eye symptoms. excessive watery (clear) discharge. sensation of grittiness. redness and burning."
},
{
"NDCCode": "55037-402-10",
"PackageDescription": "1724.8 L in 1 CYLINDER (55037-402-10) ",
"NDC11Code": "55037-0402-10",
"ProductNDC": "55037-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbon Dioxide",
"NonProprietaryName": "Carbon Dioxide",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19870101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217082",
"LabelerName": "Matheson Tri-Gas, Inc.",
"SubstanceName": "CARBON DIOXIDE",
"StrengthNumber": "992",
"StrengthUnit": "mL/L",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19870101",
"SamplePackage": "N"
},
{
"NDCCode": "55111-402-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-402-78) > 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "55111-0402-78",
"ProductNDC": "55111-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077645",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-04-11",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55570-402-10",
"PackageDescription": "50 kg in 1 DRUM (55570-402-10) ",
"NDC11Code": "55570-0402-10",
"ProductNDC": "55570-402",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Caprate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210427",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Jost Chemical Co.",
"SubstanceName": "SODIUM CAPRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "27-APR-21"
},
{
"NDCCode": "57883-402-04",
"PackageDescription": "10 TUBE in 1 CARTON (57883-402-04) / 4 g in 1 TUBE",
"NDC11Code": "57883-0402-04",
"ProductNDC": "57883-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plexion",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050901",
"EndMarketingDate": "20231031",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Brava Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "98; 48",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050901",
"EndMarketingDatePackage": "20231031",
"SamplePackage": "Y"
},
{
"NDCCode": "57883-402-10",
"PackageDescription": "285 g in 1 BOTTLE, PLASTIC (57883-402-10) ",
"NDC11Code": "57883-0402-10",
"ProductNDC": "57883-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plexion",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050901",
"EndMarketingDate": "20231031",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Brava Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "98; 48",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050901",
"EndMarketingDatePackage": "20231031",
"SamplePackage": "N"
},
{
"NDCCode": "59898-402-10",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (59898-402-10) ",
"NDC11Code": "59898-0402-10",
"ProductNDC": "59898-402",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopro First Aid",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100523",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Water-Jel Technologies",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100523",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help decrease the risk of infection in minor cuts, scrapes and burns."
},
{
"NDCCode": "59898-402-15",
"PackageDescription": "24 BOTTLE, SPRAY in 1 CASE (59898-402-15) / 59 mL in 1 BOTTLE, SPRAY (59898-402-10) ",
"NDC11Code": "59898-0402-15",
"ProductNDC": "59898-402",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopro First Aid",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100523",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Water-Jel Technologies",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100523",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help decrease the risk of infection in minor cuts, scrapes and burns."
},
{
"NDCCode": "60429-402-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (60429-402-10) ",
"NDC11Code": "60429-0402-10",
"ProductNDC": "60429-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20011217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075828",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140624",
"EndMarketingDatePackage": "20210331",
"SamplePackage": "N"
},
{
"NDCCode": "61973-402-10",
"PackageDescription": "153 g in 1 CARTON (61973-402-10) ",
"NDC11Code": "61973-0402-10",
"ProductNDC": "61973-402",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arizona Sun Products Golfblok Lip Balm Spf 15",
"NonProprietaryName": "Lip Balm",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240222",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Arizona Sun Products",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": "75; 30",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240222",
"SamplePackage": "N",
"IndicationAndUsage": "Provides mminimal sunburn protection. Higher SPF gives more sunburn protection."
},
{
"NDCCode": "62541-402-10",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62541-402-10) / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS",
"NDC11Code": "62541-0402-10",
"ProductNDC": "62541-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pancreaze",
"NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100412",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA022523",
"LabelerName": "VIVUS LLC",
"SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "4200; 24600; 14200",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100412",
"SamplePackage": "N",
"IndicationAndUsage": "PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
"Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated microtablets in PANCREAZE are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. PANCREAZE (pancrelipase) delayed-release capsules are for oral administration and include a two-piece shell containing enteric-coated microtablets that are each approximately 2 mm in diameter and are available as follows."
},
{
"NDCCode": "63102-402-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (63102-402-10) ",
"NDC11Code": "63102-0402-10",
"ProductNDC": "63102-402",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Actidogesic",
"NonProprietaryName": "Dexbrompheniramine Maleate, Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161014",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "ACTIPHARMA, LLC",
"SubstanceName": "DEXBROMPHENIRAMINE MALEATE; ACETAMINOPHEN",
"StrengthNumber": "1; 500",
"StrengthUnit": "mg/1; mg/1",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161014",
"SamplePackage": "N",
"IndicationAndUsage": " For the temporary relief of minor aches and pains associated with headache muscular aches backaches minor arthritis pain common cold toothaches menstrual cramps temporarily reduces fever itchy, watery eyes due to hay fever."
},
{
"NDCCode": "63323-402-20",
"PackageDescription": "10 VIAL in 1 TRAY (63323-402-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-402-01) ",
"NDC11Code": "63323-0402-20",
"ProductNDC": "63323-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aztreonam",
"NonProprietaryName": "Aztreonam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20091105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065439",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "AZTREONAM",
"StrengthNumber": "2",
"StrengthUnit": "g/1",
"Pharm_Classes": "Monobactam Antibacterial [EPC], Monobactams [CS]",
"Status": "Active",
"LastUpdate": "2022-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091105",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of aztreonam for injection, USP and other antibacterial drugs, aztreonam for injection 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. Aztreonam for Injection is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms:. Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytoca*, Citrobacter species*, and Serratia marcescens*. Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, and Serratia marcescens*. Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis*, Serratia marcescens*, and Enterobacter species. Skin and Skin-Structure Infections, including those associated with postoperative wounds, ulcers, and burns, caused by Escherichia coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Citrobacter species*. *Efficacy for this organism in this organ system was studied in fewer than 10 infections. Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella species including K. pneumoniae, Enterobacter species including E. cloacae*, Pseudomonas aeruginosa, Citrobacter species* including C. freundii*, and Serratia species* including S. marcescens*. Gynecologic Infections, including endometritis and pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae*, Enterobacter species* including E. cloacae*, and Proteus mirabilis*. Aztreonam for injection is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections, and infections of serous surfaces. Aztreonam for injection is effective against most of the commonly encountered Gram-negative aerobic pathogens seen in general surgery.",
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"Description": "Aztreonam for Injection, USP contains the active ingredient aztreonam, a monobactam. It was originally isolated from Chromobacterium violaceum. It is a synthetic bactericidal antibiotic. The monobactams, having a unique monocyclic beta-lactam nucleus, are structurally different from other beta-lactam antibiotics (e.g., penicillins, cephalosporins, cephamycins). The sulfonic acid substituent in the 1-position of the ring activates the beta-lactam moiety; an aminothiazolyl oxime side chain in the 3-position and a methyl group in the 4-position confer the specific antibacterial spectrum and beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl] carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Structural formula:. C13H17N5O8S2 M.W. 435.44. Aztreonam for injection is a sterile, nonpyrogenic, sodium-free lyophilized, off-white to slightly yellow solid containing approximately 780 mg arginine per gram of aztreonam. Following constitution, the product is for intramuscular or intravenous use. Aqueous solutions of the product have a pH in the range of 4.5 to 7.5. Each 1 gram vial contains 1 gram aztreonam with approximately 780 mg arginine. Each 2 gram vial contains 2 grams aztreonam with approximately 1.56 grams arginine."
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<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>25021-402-10</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (25021-402-10) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0402-10</NDC11Code>
<ProductNDC>25021-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100706</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090808</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>5000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease , 3 Atrial fibrillation with embolization , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation) , 5 Prevention of clotting in arterial and cardiac surgery , 6 Prophylaxis and treatment of peripheral arterial embolism , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures .</IndicationAndUsage>
<Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated, O-sulfated, or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucuronic acid). Structure of heparin sodium (representative subunits):. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Heparin Sodium Injection, USP preserved with Benzyl Alcohol is available in the following concentrations per mL:. pH 5.0 to 7.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>33342-402-10</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (33342-402-10) </PackageDescription>
<NDC11Code>33342-0402-10</NDC11Code>
<ProductNDC>33342-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211417</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown: Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each Levothyroxine sodium tablets, USP contains the inactive ingredients croscarmellose sodium, microcrystalline cellulose, silicon dioxide and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Table 9: Levothyroxine Sodium Tablet Color Additives. * Note - FD&C Yellow No. 6 is orange in color. Levothyroxine Sodium Tablet, USP meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>35418-402-10</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (35418-402-10) </PackageDescription>
<NDC11Code>35418-0402-10</NDC11Code>
<ProductNDC>35418-402</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopropyl Alcohol</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100708</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Zee Medical</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2017-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37000-402-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (37000-402-01) * 473 mL in 1 BOTTLE, PLASTIC (37000-032-04) * 8 CELLO PACK in 1 CARTON (37000-477-10) > 6 TABLET in 1 CELLO PACK</PackageDescription>
<NDC11Code>37000-0402-01</NDC11Code>
<ProductNDC>37000-402</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pepto-bismol</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110912</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42998-402-05</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (42998-402-05) > 5 mL in 1 AMPULE</PackageDescription>
<NDC11Code>42998-0402-05</NDC11Code>
<ProductNDC>42998-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isuprel</ProprietaryName>
<NonProprietaryName>Isoproterenol Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20131201</StartMarketingDate>
<EndMarketingDate>20160831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA010515</ApplicationNumber>
<LabelerName>Marathon Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ISOPROTERENOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>43547-402-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (43547-402-10) </PackageDescription>
<NDC11Code>43547-0402-10</NDC11Code>
<ProductNDC>43547-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076796</ApplicationNumber>
<LabelerName>Solco Healthcare LLC</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20 mg, 40 mg and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>49643-402-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49643-402-10) </PackageDescription>
<NDC11Code>49643-0402-10</NDC11Code>
<ProductNDC>49643-402</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>White Oak Pollen</ProprietaryName>
<NonProprietaryName>Quercus Alba</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>QUERCUS ALBA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>50458-402-02</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (50458-402-02) > 10 mL in 1 VIAL, SINGLE-USE (50458-402-01)</PackageDescription>
<NDC11Code>50458-0402-02</NDC11Code>
<ProductNDC>50458-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doribax</ProprietaryName>
<NonProprietaryName>Doripenem</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20101015</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022106</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DORIPENEM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-01-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>51206-402-01</NDCCode>
<PackageDescription>10 TRAY in 1 BOX (51206-402-01) > 1.87 mL in 1 TRAY</PackageDescription>
<NDC11Code>51206-0402-01</NDC11Code>
<ProductNDC>51206-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flor-opal Sustained-release Fluoride</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20050301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Ultradent Products, Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-12-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>52958-402-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (52958-402-01) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>52958-0402-01</NDC11Code>
<ProductNDC>52958-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eptifibatide</ProprietaryName>
<NonProprietaryName>Eptifibatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210907</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213081</ApplicationNumber>
<LabelerName>Hainan Shuangcheng Pharmaceuticals Co., Ltd.</LabelerName>
<SubstanceName>EPTIFIBATIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210907</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eptifibatide injection is a platelet aggregation inhibitor indicated for: 1 Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) (1.1), 2 Treatment of patients undergoing PCI (including intracoronary stenting) (1.2).</IndicationAndUsage>
<Description>Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N6-(aminoiminomethyl)-N2-(3-mercapto-1-oxopropyl)-L-lysylglycyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1→6)-disulfide. Eptifibatide binds to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets and inhibits platelet aggregation. The eptifibatide peptide is produced by solid-phase peptide synthesis, and is purified by preparative reverse-phase liquid chromatography and lyophilized. The structural formula is. Eptifibatide Injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous (IV) use with an empirical formula of C35H49N11O9S2 and a molecular weight of 831.96. Each 10-mL vial contains 2 mg/mL of eptifibatide and each 100-mL vial contains 0.75 mg/mL of eptifibatide. Each vial of either size also contains 5.25 mg/mL citric acid and sodium hydroxide to adjust the pH to 5.35.</Description>
</NDC>
<NDC>
<NDCCode>53799-402-11</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (53799-402-11) > 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>53799-0402-11</NDC11Code>
<ProductNDC>53799-402</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pink Eye</ProprietaryName>
<NonProprietaryName>Atropa Belladonna, Euphrasia Stricta, Calcium Sulfide</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20190215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Similasan AG</LabelerName>
<SubstanceName>ATROPA BELLADONNA; CALCIUM SULFIDE; EUPHRASIA STRICTA</SubstanceName>
<StrengthNumber>6; 12; 6</StrengthNumber>
<StrengthUnit>[hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>According to homeopathic principles, the active ingredients in this product temporarily relieve minor eye symptoms. excessive watery (clear) discharge. sensation of grittiness. redness and burning.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55037-402-10</NDCCode>
<PackageDescription>1724.8 L in 1 CYLINDER (55037-402-10) </PackageDescription>
<NDC11Code>55037-0402-10</NDC11Code>
<ProductNDC>55037-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbon Dioxide</ProprietaryName>
<NonProprietaryName>Carbon Dioxide</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19870101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217082</ApplicationNumber>
<LabelerName>Matheson Tri-Gas, Inc.</LabelerName>
<SubstanceName>CARBON DIOXIDE</SubstanceName>
<StrengthNumber>992</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55111-402-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-402-78) > 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55111-0402-78</NDC11Code>
<ProductNDC>55111-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077645</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-11</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55570-402-10</NDCCode>
<PackageDescription>50 kg in 1 DRUM (55570-402-10) </PackageDescription>
<NDC11Code>55570-0402-10</NDC11Code>
<ProductNDC>55570-402</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sodium Caprate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20210427</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Jost Chemical Co.</LabelerName>
<SubstanceName>SODIUM CAPRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-APR-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>57883-402-04</NDCCode>
<PackageDescription>10 TUBE in 1 CARTON (57883-402-04) / 4 g in 1 TUBE</PackageDescription>
<NDC11Code>57883-0402-04</NDC11Code>
<ProductNDC>57883-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plexion</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050901</StartMarketingDate>
<EndMarketingDate>20231031</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Brava Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>98; 48</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050901</StartMarketingDatePackage>
<EndMarketingDatePackage>20231031</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>57883-402-10</NDCCode>
<PackageDescription>285 g in 1 BOTTLE, PLASTIC (57883-402-10) </PackageDescription>
<NDC11Code>57883-0402-10</NDC11Code>
<ProductNDC>57883-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plexion</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050901</StartMarketingDate>
<EndMarketingDate>20231031</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Brava Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>98; 48</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050901</StartMarketingDatePackage>
<EndMarketingDatePackage>20231031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59898-402-10</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (59898-402-10) </PackageDescription>
<NDC11Code>59898-0402-10</NDC11Code>
<ProductNDC>59898-402</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopro First Aid</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100523</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Water-Jel Technologies</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help decrease the risk of infection in minor cuts, scrapes and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59898-402-15</NDCCode>
<PackageDescription>24 BOTTLE, SPRAY in 1 CASE (59898-402-15) / 59 mL in 1 BOTTLE, SPRAY (59898-402-10) </PackageDescription>
<NDC11Code>59898-0402-15</NDC11Code>
<ProductNDC>59898-402</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopro First Aid</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100523</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Water-Jel Technologies</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help decrease the risk of infection in minor cuts, scrapes and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60429-402-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (60429-402-10) </PackageDescription>
<NDC11Code>60429-0402-10</NDC11Code>
<ProductNDC>60429-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075828</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140624</StartMarketingDatePackage>
<EndMarketingDatePackage>20210331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61973-402-10</NDCCode>
<PackageDescription>153 g in 1 CARTON (61973-402-10) </PackageDescription>
<NDC11Code>61973-0402-10</NDC11Code>
<ProductNDC>61973-402</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arizona Sun Products Golfblok Lip Balm Spf 15</ProprietaryName>
<NonProprietaryName>Lip Balm</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240222</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Arizona Sun Products</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>75; 30</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Provides mminimal sunburn protection. Higher SPF gives more sunburn protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62541-402-10</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62541-402-10) / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62541-0402-10</NDC11Code>
<ProductNDC>62541-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pancreaze</ProprietaryName>
<NonProprietaryName>Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100412</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA022523</ApplicationNumber>
<LabelerName>VIVUS LLC</LabelerName>
<SubstanceName>PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>4200; 24600; 14200</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<Description>Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated microtablets in PANCREAZE are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. PANCREAZE (pancrelipase) delayed-release capsules are for oral administration and include a two-piece shell containing enteric-coated microtablets that are each approximately 2 mm in diameter and are available as follows.</Description>
</NDC>
<NDC>
<NDCCode>63102-402-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (63102-402-10) </PackageDescription>
<NDC11Code>63102-0402-10</NDC11Code>
<ProductNDC>63102-402</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Actidogesic</ProprietaryName>
<NonProprietaryName>Dexbrompheniramine Maleate, Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161014</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>ACTIPHARMA, LLC</LabelerName>
<SubstanceName>DEXBROMPHENIRAMINE MALEATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>1; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> For the temporary relief of minor aches and pains associated with headache muscular aches backaches minor arthritis pain common cold toothaches menstrual cramps temporarily reduces fever itchy, watery eyes due to hay fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63323-402-20</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (63323-402-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-402-01) </PackageDescription>
<NDC11Code>63323-0402-20</NDC11Code>
<ProductNDC>63323-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aztreonam</ProprietaryName>
<NonProprietaryName>Aztreonam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20091105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065439</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>AZTREONAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Monobactam Antibacterial [EPC], Monobactams [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of aztreonam for injection, USP and other antibacterial drugs, aztreonam for injection 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. Aztreonam for Injection is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms:. Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytoca*, Citrobacter species*, and Serratia marcescens*. Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, and Serratia marcescens*. Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis*, Serratia marcescens*, and Enterobacter species. Skin and Skin-Structure Infections, including those associated with postoperative wounds, ulcers, and burns, caused by Escherichia coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Citrobacter species*. *Efficacy for this organism in this organ system was studied in fewer than 10 infections. Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella species including K. pneumoniae, Enterobacter species including E. cloacae*, Pseudomonas aeruginosa, Citrobacter species* including C. freundii*, and Serratia species* including S. marcescens*. Gynecologic Infections, including endometritis and pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae*, Enterobacter species* including E. cloacae*, and Proteus mirabilis*. Aztreonam for injection is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections, and infections of serous surfaces. Aztreonam for injection is effective against most of the commonly encountered Gram-negative aerobic pathogens seen in general surgery.</IndicationAndUsage>
<Description>Aztreonam for Injection, USP contains the active ingredient aztreonam, a monobactam. It was originally isolated from Chromobacterium violaceum. It is a synthetic bactericidal antibiotic. The monobactams, having a unique monocyclic beta-lactam nucleus, are structurally different from other beta-lactam antibiotics (e.g., penicillins, cephalosporins, cephamycins). The sulfonic acid substituent in the 1-position of the ring activates the beta-lactam moiety; an aminothiazolyl oxime side chain in the 3-position and a methyl group in the 4-position confer the specific antibacterial spectrum and beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl] carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Structural formula:. Aztreonam for injection is a sterile, nonpyrogenic, sodium-free lyophilized, off-white to slightly yellow solid containing approximately 780 mg arginine per gram of aztreonam. Following constitution, the product is for intramuscular or intravenous use. Aqueous solutions of the product have a pH in the range of 4.5 to 7.5. Each 1 gram vial contains 1 gram aztreonam with approximately 780 mg arginine. Each 2 gram vial contains 2 grams aztreonam with approximately 1.56 grams arginine.</Description>
</NDC>
<NDC>
<NDCCode>63323-402-24</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (63323-402-24) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-402-41) </PackageDescription>
<NDC11Code>63323-0402-24</NDC11Code>
<ProductNDC>63323-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aztreonam</ProprietaryName>
<NonProprietaryName>Aztreonam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20091105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065439</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>AZTREONAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Monobactam Antibacterial [EPC], Monobactams [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of aztreonam for injection, USP and other antibacterial drugs, aztreonam for injection 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. Aztreonam for Injection is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms:. Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytoca*, Citrobacter species*, and Serratia marcescens*. Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, and Serratia marcescens*. Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis*, Serratia marcescens*, and Enterobacter species. Skin and Skin-Structure Infections, including those associated with postoperative wounds, ulcers, and burns, caused by Escherichia coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Citrobacter species*. *Efficacy for this organism in this organ system was studied in fewer than 10 infections. Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella species including K. pneumoniae, Enterobacter species including E. cloacae*, Pseudomonas aeruginosa, Citrobacter species* including C. freundii*, and Serratia species* including S. marcescens*. Gynecologic Infections, including endometritis and pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae*, Enterobacter species* including E. cloacae*, and Proteus mirabilis*. Aztreonam for injection is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections, and infections of serous surfaces. Aztreonam for injection is effective against most of the commonly encountered Gram-negative aerobic pathogens seen in general surgery.</IndicationAndUsage>
<Description>Aztreonam for Injection, USP contains the active ingredient aztreonam, a monobactam. It was originally isolated from Chromobacterium violaceum. It is a synthetic bactericidal antibiotic. The monobactams, having a unique monocyclic beta-lactam nucleus, are structurally different from other beta-lactam antibiotics (e.g., penicillins, cephalosporins, cephamycins). The sulfonic acid substituent in the 1-position of the ring activates the beta-lactam moiety; an aminothiazolyl oxime side chain in the 3-position and a methyl group in the 4-position confer the specific antibacterial spectrum and beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl] carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Structural formula:. C13H17N5O8S2 M.W. 435.44. Aztreonam for injection is a sterile, nonpyrogenic, sodium-free lyophilized, off-white to slightly yellow solid containing approximately 780 mg arginine per gram of aztreonam. Following constitution, the product is for intramuscular or intravenous use. Aqueous solutions of the product have a pH in the range of 4.5 to 7.5. Each 1 gram vial contains 1 gram aztreonam with approximately 780 mg arginine. Each 2 gram vial contains 2 grams aztreonam with approximately 1.56 grams arginine.</Description>
</NDC>
</NDCList>