{
"NDC": [
{
"NDCCode": "69918-901-10",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-10) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "69918-0901-10",
"ProductNDC": "69918-901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018938",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160120",
"SamplePackage": "N",
"IndicationAndUsage": "Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).",
"Description": "Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
},
{
"NDCCode": "69918-901-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-11) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "69918-0901-11",
"ProductNDC": "69918-901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220107",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018938",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220107",
"SamplePackage": "N",
"IndicationAndUsage": "Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).",
"Description": "Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
},
{
"NDCCode": "69918-901-12",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-12) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "69918-0901-12",
"ProductNDC": "69918-901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220509",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018938",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2025-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220509",
"SamplePackage": "N",
"IndicationAndUsage": "Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).",
"Description": "Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
},
{
"NDCCode": "69918-601-60",
"PackageDescription": "60 POUCH in 1 CARTON (69918-601-60) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER",
"NDC11Code": "69918-0601-60",
"ProductNDC": "69918-601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timoptic In Ocudose",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212592",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220226",
"SamplePackage": "N",
"IndicationAndUsage": "Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution USP, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.",
"Description": "Timolol maleate USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied in two formulations: timolol maleate ophthalmic solution, which contains the preservative benzalkonium chloride; and timolol maleate ophthalmic solution, the preservative-free formulation. Preservative-free timolol maleate ophthalmic solution, USP is supplied in a single-dose vial, as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of preservative-free timolol maleate ophthalmic solution USP 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of Preservative-free timolol maleate ophthalmic solution USP 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection."
},
{
"NDCCode": "69918-602-60",
"PackageDescription": "60 POUCH in 1 CARTON (69918-602-60) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER",
"NDC11Code": "69918-0602-60",
"ProductNDC": "69918-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timoptic In Ocudose",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212592",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220226",
"SamplePackage": "N",
"IndicationAndUsage": "Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution USP, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.",
"Description": "Timolol maleate USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied in two formulations: timolol maleate ophthalmic solution, which contains the preservative benzalkonium chloride; and timolol maleate ophthalmic solution, the preservative-free formulation. Preservative-free timolol maleate ophthalmic solution, USP is supplied in a single-dose vial, as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of preservative-free timolol maleate ophthalmic solution USP 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of Preservative-free timolol maleate ophthalmic solution USP 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection."
},
{
"NDCCode": "69918-700-10",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (69918-700-10) > 10 mL in 1 VIAL, MULTI-DOSE (69918-700-01) ",
"NDC11Code": "69918-0700-10",
"ProductNDC": "69918-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Succinylcholine Chloride",
"NonProprietaryName": "Succinylcholine Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210231",
"LabelerName": "Amring Pharmaceuticals Inc.",
"SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
"Status": "Active",
"LastUpdate": "2022-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190410",
"SamplePackage": "N",
"IndicationAndUsage": "Succinylcholine chloride is indicated in adults and pediatric patients: : 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:. Succinylcholine chloride 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.65 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
},
{
"NDCCode": "69918-700-11",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (69918-700-11) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-04) ",
"NDC11Code": "69918-0700-11",
"ProductNDC": "69918-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Succinylcholine Chloride",
"NonProprietaryName": "Succinylcholine Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20221021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214308",
"LabelerName": "Amring Pharmaceuticals Inc.",
"SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20221021",
"SamplePackage": "N",
"IndicationAndUsage": "Succinylcholine chloride injection is indicated in adults and pediatric patients: : 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride injection contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:. Succinylcholine chloride injection 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride injection 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.70 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
},
{
"NDCCode": "69918-700-12",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (69918-700-12) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-05) ",
"NDC11Code": "69918-0700-12",
"ProductNDC": "69918-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Succinylcholine Chloride",
"NonProprietaryName": "Succinylcholine Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20240520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216003",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240520",
"SamplePackage": "N",
"IndicationAndUsage": "Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection, USP contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4.2H2O and its molecular weight is 397.34. The chemical name of succinylcholine chloride is 2,2’-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N-trimethyl-ethanaminium]dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white or almost white, odorless, crystalline powder, freely soluble in water. It has the following structural formula. Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine chloride, USP (equivalent to 22 mg of Succinylcholine Chloride dihydrate, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.8 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
},
{
"NDCCode": "69918-700-25",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (69918-700-25) > 10 mL in 1 VIAL, MULTI-DOSE (69918-700-01) ",
"NDC11Code": "69918-0700-25",
"ProductNDC": "69918-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Succinylcholine Chloride",
"NonProprietaryName": "Succinylcholine Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210231",
"LabelerName": "Amring Pharmaceuticals Inc.",
"SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
"Status": "Active",
"LastUpdate": "2022-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190410",
"SamplePackage": "N",
"IndicationAndUsage": "Succinylcholine chloride is indicated in adults and pediatric patients: : 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:. Succinylcholine chloride 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.65 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
},
{
"NDCCode": "69918-700-26",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (69918-700-26) > 10 mL in 1 VIAL, MULTI-DOSE (69918-700-02) ",
"NDC11Code": "69918-0700-26",
"ProductNDC": "69918-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Succinylcholine Chloride",
"NonProprietaryName": "Succinylcholine Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20191004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210231",
"LabelerName": "Amring Pharmaceuticals Inc.",
"SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20191004",
"SamplePackage": "N",
"IndicationAndUsage": "Succinylcholine chloride is indicated in adults and pediatric patients: : 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula. Succinylcholine chloride 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.65 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
},
{
"NDCCode": "69918-700-27",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (69918-700-27) > 10 mL in 1 VIAL, MULTI-DOSE (69918-700-03) ",
"NDC11Code": "69918-0700-27",
"ProductNDC": "69918-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Succinylcholine Chloride",
"NonProprietaryName": "Succinylcholine Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214308",
"LabelerName": "Amring Pharmaceuticals Inc.",
"SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220908",
"SamplePackage": "N",
"IndicationAndUsage": "Succinylcholine chloride injection is indicated in adults and pediatric patients: : 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride injection contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula. Succinylcholine chloride injection 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride injection 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.70 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
},
{
"NDCCode": "69918-700-28",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (69918-700-28) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-04) ",
"NDC11Code": "69918-0700-28",
"ProductNDC": "69918-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Succinylcholine Chloride",
"NonProprietaryName": "Succinylcholine Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20221021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214308",
"LabelerName": "Amring Pharmaceuticals Inc.",
"SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20221021",
"SamplePackage": "N",
"IndicationAndUsage": "Succinylcholine chloride injection is indicated in adults and pediatric patients: : 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride injection contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:. Succinylcholine chloride injection 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride injection 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.70 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
},
{
"NDCCode": "69918-700-29",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (69918-700-29) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-05) ",
"NDC11Code": "69918-0700-29",
"ProductNDC": "69918-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Succinylcholine Chloride",
"NonProprietaryName": "Succinylcholine Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20240520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216003",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240520",
"SamplePackage": "N",
"IndicationAndUsage": "Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection, USP contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4.2H2O and its molecular weight is 397.34. The chemical name of succinylcholine chloride is 2,2’-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N-trimethyl-ethanaminium]dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white or almost white, odorless, crystalline powder, freely soluble in water. It has the following structural formula. Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine chloride, USP (equivalent to 22 mg of Succinylcholine Chloride dihydrate, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.8 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
},
{
"NDCCode": "69918-720-02",
"PackageDescription": "2 VIAL, GLASS in 1 CARTON (69918-720-02) / 10 mL in 1 VIAL, GLASS (69918-720-01) ",
"NDC11Code": "69918-0720-02",
"ProductNDC": "69918-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arsenic Trioxide",
"NonProprietaryName": "Arsenic Trioxide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210802",
"LabelerName": "Amring Pharmaceuticals Inc.",
"SubstanceName": "ARSENIC TRIOXIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181114",
"SamplePackage": "N",
"IndicationAndUsage": "Arsenic trioxide is an arsenical indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.2).",
"Description": "Arsenic trioxide injection is a sterile injectable solution of arsenic trioxide. The molecular formula of arsenic trioxide in the solid state is As2O3, with a molecular weight of 197.8 and the following structural formula. Arsenic trioxide injection is available in 10 mL, single-dose glass vials containing 10 mg of arsenic trioxide. Arsenic trioxide injection is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. Arsenic trioxide injection is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 1 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) for solubilization, and sodium hydroxide and hydrochloric acid for pH adjustment to pH 8."
},
{
"NDCCode": "69918-720-10",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (69918-720-10) / 10 mL in 1 VIAL, GLASS (69918-720-01) ",
"NDC11Code": "69918-0720-10",
"ProductNDC": "69918-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arsenic Trioxide",
"NonProprietaryName": "Arsenic Trioxide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210802",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "ARSENIC TRIOXIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181114",
"SamplePackage": "N",
"IndicationAndUsage": "Arsenic trioxide is an arsenical indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.2).",
"Description": "Arsenic trioxide injection is a sterile injectable solution of arsenic trioxide. The molecular formula of arsenic trioxide in the solid state is As2O3, with a molecular weight of 197.8 and the following structural formula. Arsenic trioxide injection is available in 10 mL, single-dose glass vials containing 10 mg of arsenic trioxide. Arsenic trioxide injection is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. Arsenic trioxide injection is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 1 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) for solubilization, and sodium hydroxide and hydrochloric acid for pH adjustment to pH 8."
},
{
"NDCCode": "69918-731-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (69918-731-10) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "69918-0731-10",
"ProductNDC": "69918-731",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isoproterenol Hydrochloride",
"NonProprietaryName": "Isoproterenol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20210801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211237",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "ISOPROTERENOL HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210801",
"SamplePackage": "N",
"IndicationAndUsage": "Isoproterenol hydrochloride injection is indicated: 1 To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output, 2 For bronchospasm occurring during anesthesia.",
"Description": "Isoproterenol hydrochloride, USP is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. The molecular formula is C11H17NO3 HCl. It has a molecular weight of 247.72 and the following structural formula. Isoproterenol hydrochloride, USP is a racemic compound. The pH is adjusted between 2.5 and 4.5 with hydrochloric acid or sodium hydroxide. The sterile solution is nonpyrogenic and can be administered by the intravenous, intramuscular, subcutaneous, or intracardiac routes."
},
{
"NDCCode": "69918-731-11",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (69918-731-11) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "69918-0731-11",
"ProductNDC": "69918-731",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isoproterenol Hydrochloride",
"NonProprietaryName": "Isoproterenol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20240601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211237",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "ISOPROTERENOL HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240601",
"SamplePackage": "N",
"IndicationAndUsage": "Isoproterenol hydrochloride injection is indicated: 1 To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output, 2 For bronchospasm occurring during anesthesia.",
"Description": "Isoproterenol hydrochloride, USP is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. The molecular formula is C11H17NO3 HCl. It has a molecular weight of 247.72 and the following structural formula. Isoproterenol hydrochloride, USP is a racemic compound. The pH is adjusted between 2.5 and 4.5 with hydrochloric acid or sodium hydroxide. The sterile solution is nonpyrogenic and can be administered by the intravenous, intramuscular, subcutaneous, or intracardiac routes."
},
{
"NDCCode": "69918-735-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (69918-735-10) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "69918-0735-10",
"ProductNDC": "69918-735",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isoproterenol Hydrochloride",
"NonProprietaryName": "Isoproterenol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20210801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211237",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "ISOPROTERENOL HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210801",
"SamplePackage": "N",
"IndicationAndUsage": "Isoproterenol hydrochloride injection is indicated: 1 To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output, 2 For bronchospasm occurring during anesthesia.",
"Description": "Isoproterenol hydrochloride, USP is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. The molecular formula is C11H17NO3 HCl. It has a molecular weight of 247.72 and the following structural formula. Isoproterenol hydrochloride, USP is a racemic compound. The pH is adjusted between 2.5 and 4.5 with hydrochloric acid or sodium hydroxide. The sterile solution is nonpyrogenic and can be administered by the intravenous, intramuscular, subcutaneous, or intracardiac routes."
},
{
"NDCCode": "69918-735-11",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (69918-735-11) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "69918-0735-11",
"ProductNDC": "69918-735",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isoproterenol Hydrochloride",
"NonProprietaryName": "Isoproterenol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20240601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211237",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "ISOPROTERENOL HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240601",
"SamplePackage": "N",
"IndicationAndUsage": "Isoproterenol hydrochloride injection is indicated: 1 To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output, 2 For bronchospasm occurring during anesthesia.",
"Description": "Isoproterenol hydrochloride, USP is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. The molecular formula is C11H17NO3 HCl. It has a molecular weight of 247.72 and the following structural formula. Isoproterenol hydrochloride, USP is a racemic compound. The pH is adjusted between 2.5 and 4.5 with hydrochloric acid or sodium hydroxide. The sterile solution is nonpyrogenic and can be administered by the intravenous, intramuscular, subcutaneous, or intracardiac routes."
},
{
"NDCCode": "69918-899-10",
"PackageDescription": "10 AMPULE in 1 CARTON (69918-899-10) / 1 mL in 1 AMPULE",
"NDC11Code": "69918-0899-10",
"ProductNDC": "69918-899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018938",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160120",
"SamplePackage": "N",
"IndicationAndUsage": "Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).",
"Description": "Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
},
{
"NDCCode": "69918-899-11",
"PackageDescription": "10 AMPULE in 1 CARTON (69918-899-11) / 1 mL in 1 AMPULE",
"NDC11Code": "69918-0899-11",
"ProductNDC": "69918-899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220107",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018938",
"LabelerName": "Nordic Pharma, Inc.",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220107",
"SamplePackage": "N",
"IndicationAndUsage": "Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).",
"Description": "Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
},
{
"NDCCode": "14789-901-10",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (14789-901-10) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "14789-0901-10",
"ProductNDC": "14789-901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Procainamide Hydrochloride",
"NonProprietaryName": "Procainamide Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20071014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206332",
"LabelerName": "Nexus Pharmaceuticals LLC",
"SubstanceName": "PROCAINAMIDE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20071014",
"SamplePackage": "N",
"IndicationAndUsage": "Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of procainamide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (see WARNINGSand Boxed Warning.).",
"Description": "Procainamide Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of procainamide hydrochloride in water for injection. Each milliliter of the 2 mL vial contains procainamide hydrochloride 500 mg; methylparaben 1 mg and sodium metabisulfite 1.8 mg added in water for injection. Each milliliter of the 10 mL vial contains procainamide hydrochloride 100 mg; methylparaben 1 mg and sodium metabisulfite 0.8 mg added in water for injection. In both formulations, the solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.0 (4.0 to 6.0). Headspace nitrogen gassed. Procainamide Hydrochloride Injection is intended for intravenous or intramuscular administration. Procainamide hydrochloride, a Group 1A cardiac antiarrhythmic drug, is p-amino-N-[2-(diethylamino) ethyl] benzamide mono- hydrochloride. It has the following structural formula. *(locus for acetylation to N-acetyl procainamide). It differs from procaine which is the p-aminobenzoyl ester of 2-(diethylamino)-ethanol. Procainamide as the free base has a pKa of 9.23; the monohydrochloride is very soluble in water."
},
{
"NDCCode": "19515-901-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (19515-901-52) > .5 mL in 1 SYRINGE (19515-901-41)",
"NDC11Code": "19515-0901-52",
"ProductNDC": "19515-901",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Flulaval Quadrivalent",
"ProprietaryNameSuffix": "2015/2016",
"NonProprietaryName": "Influenza Virus Vaccine",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20150701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125163",
"LabelerName": "ID Biomedical Corporation of Quebec",
"SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "15; 15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "23155-901-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (23155-901-10) ",
"NDC11Code": "23155-0901-10",
"ProductNDC": "23155-901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074225",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240628",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide Tablets USP are a loop diuretic available as 0.5 mg (white to off-white), 1 mg (white to off-white) and 2 mg (white to off-white) tablets for oral administration; each tablet also contains: anhydrous lactose, corn starch, magnesium stearate, microcrystalline cellulose and talc. Chemically, bumetanide, USP is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder. It is slightly soluble in water and soluble in alkaline solutions. It has the following structural formula. Meets USP Dissolution Test 2."
},
{
"NDCCode": "24208-901-99",
"PackageDescription": "1 KIT in 1 CARTON (24208-901-99) * 1 mL in 1 BOTTLE, DROPPER * 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "24208-0901-99",
"ProductNDC": "24208-901",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alaway",
"NonProprietaryName": "Ketotifen Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20061201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021996",
"LabelerName": "Bausch & Lomb Incorporated",
"Status": "Deprecated",
"LastUpdate": "2020-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20061201",
"SamplePackage": "N"
},
{
"NDCCode": "31720-901-10",
"PackageDescription": "50 mL in 1 TUBE (31720-901-10)",
"NDC11Code": "31720-0901-10",
"ProductNDC": "31720-901",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sephora Perfecting Tinted Moisturizer Light 15 Nude",
"ProprietaryNameSuffix": "Spf 20",
"NonProprietaryName": "Octinoxate, Octisalate And Avobenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "S+",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "3; 7.5; 5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2014-06-23"
},
{
"NDCCode": "31722-901-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-901-10)",
"NDC11Code": "31722-0901-10",
"ProductNDC": "31722-901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel",
"NonProprietaryName": "Clopidogrel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204165",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Clopidogrel is a P2Y12 platelet inhibitor indicated for:. · Acute coronary syndrome. - For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], Clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1). - For patients with ST-elevation myocardial infarction (STEMI), Clopidogrel has been shown to reduce the rate of MI and stroke. (1.1). · Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. (1.2).",
"Description": "Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is freely soluble in methanol, practically insoluble in ether. It has a specific optical rotation of about +56°. Clopidogrel for oral administration is provided as either pink colored, round shaped, biconvex, de-bossed, film coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink colored, modified oval shaped, de-bossed film coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose and hydrogenated castor oil as inactive ingredients. The film coating contains hypromellose, titanium dioxide, polyethylene glycol and red iron oxide."
},
{
"NDCCode": "37012-901-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (37012-901-10) > 30 mL in 1 BOTTLE",
"NDC11Code": "37012-0901-10",
"ProductNDC": "37012-901",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasal",
"NonProprietaryName": "Oxymetazoline Hydrochloride",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20160803",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Shopko Stores Operating Co., LLC",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160803",
"SamplePackage": "N"
},
{
"NDCCode": "43598-901-58",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (43598-901-58) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (43598-901-11) ",
"NDC11Code": "43598-0901-58",
"ProductNDC": "43598-901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ertapenem Sodium",
"NonProprietaryName": "Ertapenem",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20210429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212040",
"LabelerName": "Dr.Reddys Laboratories Inc.,",
"SubstanceName": "ERTAPENEM SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210429",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ertapenem for injection and other antibacterial drugs, Ertapenem 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. Treatment. Ertapenem for injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with the following moderate to severe infections caused by susceptible isolates of the designated microorganisms [see Dosage and Administration (2)].",
"Description": "Ertapenem for injection is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics. Chemically, Ertapenem for injection is described as [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt. Its molecular weight is 497.50. The empirical formula is C22H24N3O7SNa, and its structural formula is. Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran. Ertapenem for Injection is supplied as sterile lyophilized powder for intravenous infusion after reconstitution with appropriate diluent [see Dosage and Administration (2.7)] and transfer to 50 mL 0.9% Sodium Chloride Injection or for intramuscular injection following reconstitution with 1% lidocaine hydrochloride. Each single-dose vial contains 1 gram ertapenem equivalent to 1.046 grams ertapenem sodium. The sodium content is approximately 137 mg (approximately 6.0 mEq). Each vial of Ertapenem for Injection contains the following inactive ingredients: 175 mg sodium bicarbonate and sodium hydroxide to adjust pH to 7.5."
},
{
"NDCCode": "46144-901-10",
"PackageDescription": "1000 g in 1 BOTTLE, PLASTIC (46144-901-10)",
"NDC11Code": "46144-0901-10",
"ProductNDC": "46144-901",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ketoprofen",
"DosageFormName": "POWDER",
"StartMarketingDate": "20121119",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "API Solutions, Inc.",
"SubstanceName": "KETOPROFEN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
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<NDCList>
<NDC>
<NDCCode>69918-901-10</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-10) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
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<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).</IndicationAndUsage>
<Description>Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>69918-901-11</NDCCode>
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<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
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<StartMarketingDate>20220107</StartMarketingDate>
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<LabelerName>Nordic Pharma, Inc.</LabelerName>
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<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).</IndicationAndUsage>
<Description>Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>69918-901-12</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-12) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
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<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
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<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220509</StartMarketingDate>
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<LabelerName>Nordic Pharma, Inc.</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).</IndicationAndUsage>
<Description>Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>69918-601-60</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (69918-601-60) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>69918-0601-60</NDC11Code>
<ProductNDC>69918-601</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timoptic In Ocudose</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212592</ApplicationNumber>
<LabelerName>Nordic Pharma, Inc.</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution USP, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.</IndicationAndUsage>
<Description>Timolol maleate USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied in two formulations: timolol maleate ophthalmic solution, which contains the preservative benzalkonium chloride; and timolol maleate ophthalmic solution, the preservative-free formulation. Preservative-free timolol maleate ophthalmic solution, USP is supplied in a single-dose vial, as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of preservative-free timolol maleate ophthalmic solution USP 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of Preservative-free timolol maleate ophthalmic solution USP 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>69918-602-60</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (69918-602-60) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>69918-0602-60</NDC11Code>
<ProductNDC>69918-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timoptic In Ocudose</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212592</ApplicationNumber>
<LabelerName>Nordic Pharma, Inc.</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution USP, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.</IndicationAndUsage>
<Description>Timolol maleate USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied in two formulations: timolol maleate ophthalmic solution, which contains the preservative benzalkonium chloride; and timolol maleate ophthalmic solution, the preservative-free formulation. Preservative-free timolol maleate ophthalmic solution, USP is supplied in a single-dose vial, as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of preservative-free timolol maleate ophthalmic solution USP 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of Preservative-free timolol maleate ophthalmic solution USP 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>69918-700-10</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (69918-700-10) > 10 mL in 1 VIAL, MULTI-DOSE (69918-700-01) </PackageDescription>
<NDC11Code>69918-0700-10</NDC11Code>
<ProductNDC>69918-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Succinylcholine Chloride</ProprietaryName>
<NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210231</ApplicationNumber>
<LabelerName>Amring Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Succinylcholine chloride is indicated in adults and pediatric patients: : 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:. Succinylcholine chloride 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.65 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
</NDC>
<NDC>
<NDCCode>69918-700-11</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (69918-700-11) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-04) </PackageDescription>
<NDC11Code>69918-0700-11</NDC11Code>
<ProductNDC>69918-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Succinylcholine Chloride</ProprietaryName>
<NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20221021</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214308</ApplicationNumber>
<LabelerName>Amring Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Succinylcholine chloride injection is indicated in adults and pediatric patients: : 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride injection contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:. Succinylcholine chloride injection 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride injection 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.70 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
</NDC>
<NDC>
<NDCCode>69918-700-12</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (69918-700-12) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-05) </PackageDescription>
<NDC11Code>69918-0700-12</NDC11Code>
<ProductNDC>69918-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Succinylcholine Chloride</ProprietaryName>
<NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20240520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216003</ApplicationNumber>
<LabelerName>Nordic Pharma, Inc.</LabelerName>
<SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection, USP contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4.2H2O and its molecular weight is 397.34. The chemical name of succinylcholine chloride is 2,2’-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N-trimethyl-ethanaminium]dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white or almost white, odorless, crystalline powder, freely soluble in water. It has the following structural formula. Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine chloride, USP (equivalent to 22 mg of Succinylcholine Chloride dihydrate, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.8 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
</NDC>
<NDC>
<NDCCode>69918-700-25</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (69918-700-25) > 10 mL in 1 VIAL, MULTI-DOSE (69918-700-01) </PackageDescription>
<NDC11Code>69918-0700-25</NDC11Code>
<ProductNDC>69918-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Succinylcholine Chloride</ProprietaryName>
<NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210231</ApplicationNumber>
<LabelerName>Amring Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Succinylcholine chloride is indicated in adults and pediatric patients: : 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:. Succinylcholine chloride 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.65 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
</NDC>
<NDC>
<NDCCode>69918-700-26</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (69918-700-26) > 10 mL in 1 VIAL, MULTI-DOSE (69918-700-02) </PackageDescription>
<NDC11Code>69918-0700-26</NDC11Code>
<ProductNDC>69918-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Succinylcholine Chloride</ProprietaryName>
<NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20191004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210231</ApplicationNumber>
<LabelerName>Amring Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Succinylcholine chloride is indicated in adults and pediatric patients: : 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula. Succinylcholine chloride 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.65 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
</NDC>
<NDC>
<NDCCode>69918-700-27</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (69918-700-27) > 10 mL in 1 VIAL, MULTI-DOSE (69918-700-03) </PackageDescription>
<NDC11Code>69918-0700-27</NDC11Code>
<ProductNDC>69918-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Succinylcholine Chloride</ProprietaryName>
<NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20220908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214308</ApplicationNumber>
<LabelerName>Amring Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Succinylcholine chloride injection is indicated in adults and pediatric patients: : 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride injection contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula. Succinylcholine chloride injection 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride injection 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.70 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
</NDC>
<NDC>
<NDCCode>69918-700-28</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (69918-700-28) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-04) </PackageDescription>
<NDC11Code>69918-0700-28</NDC11Code>
<ProductNDC>69918-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Succinylcholine Chloride</ProprietaryName>
<NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20221021</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214308</ApplicationNumber>
<LabelerName>Amring Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Succinylcholine chloride injection is indicated in adults and pediatric patients: : 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride injection contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:. Succinylcholine chloride injection 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride injection 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.70 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
</NDC>
<NDC>
<NDCCode>69918-700-29</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (69918-700-29) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-05) </PackageDescription>
<NDC11Code>69918-0700-29</NDC11Code>
<ProductNDC>69918-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Succinylcholine Chloride</ProprietaryName>
<NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20240520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216003</ApplicationNumber>
<LabelerName>Nordic Pharma, Inc.</LabelerName>
<SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation, 3 to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection, USP contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C14H30Cl2N2O4.2H2O and its molecular weight is 397.34. The chemical name of succinylcholine chloride is 2,2’-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N-trimethyl-ethanaminium]dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white or almost white, odorless, crystalline powder, freely soluble in water. It has the following structural formula. Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine chloride, USP (equivalent to 22 mg of Succinylcholine Chloride dihydrate, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.8 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
</NDC>
<NDC>
<NDCCode>69918-720-02</NDCCode>
<PackageDescription>2 VIAL, GLASS in 1 CARTON (69918-720-02) / 10 mL in 1 VIAL, GLASS (69918-720-01) </PackageDescription>
<NDC11Code>69918-0720-02</NDC11Code>
<ProductNDC>69918-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arsenic Trioxide</ProprietaryName>
<NonProprietaryName>Arsenic Trioxide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210802</ApplicationNumber>
<LabelerName>Amring Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Arsenic trioxide is an arsenical indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.2).</IndicationAndUsage>
<Description>Arsenic trioxide injection is a sterile injectable solution of arsenic trioxide. The molecular formula of arsenic trioxide in the solid state is As2O3, with a molecular weight of 197.8 and the following structural formula. Arsenic trioxide injection is available in 10 mL, single-dose glass vials containing 10 mg of arsenic trioxide. Arsenic trioxide injection is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. Arsenic trioxide injection is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 1 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) for solubilization, and sodium hydroxide and hydrochloric acid for pH adjustment to pH 8.</Description>
</NDC>
<NDC>
<NDCCode>69918-720-10</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (69918-720-10) / 10 mL in 1 VIAL, GLASS (69918-720-01) </PackageDescription>
<NDC11Code>69918-0720-10</NDC11Code>
<ProductNDC>69918-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arsenic Trioxide</ProprietaryName>
<NonProprietaryName>Arsenic Trioxide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210802</ApplicationNumber>
<LabelerName>Nordic Pharma, Inc.</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Arsenic trioxide is an arsenical indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.2).</IndicationAndUsage>
<Description>Arsenic trioxide injection is a sterile injectable solution of arsenic trioxide. The molecular formula of arsenic trioxide in the solid state is As2O3, with a molecular weight of 197.8 and the following structural formula. Arsenic trioxide injection is available in 10 mL, single-dose glass vials containing 10 mg of arsenic trioxide. Arsenic trioxide injection is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. Arsenic trioxide injection is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 1 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) for solubilization, and sodium hydroxide and hydrochloric acid for pH adjustment to pH 8.</Description>
</NDC>
<NDC>
<NDCCode>69918-731-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (69918-731-10) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>69918-0731-10</NDC11Code>
<ProductNDC>69918-731</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isoproterenol Hydrochloride</ProprietaryName>
<NonProprietaryName>Isoproterenol Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20210801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211237</ApplicationNumber>
<LabelerName>Nordic Pharma, Inc.</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>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isoproterenol hydrochloride injection is indicated: 1 To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output, 2 For bronchospasm occurring during anesthesia.</IndicationAndUsage>
<Description>Isoproterenol hydrochloride, USP is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. The molecular formula is C11H17NO3 HCl. It has a molecular weight of 247.72 and the following structural formula. Isoproterenol hydrochloride, USP is a racemic compound. The pH is adjusted between 2.5 and 4.5 with hydrochloric acid or sodium hydroxide. The sterile solution is nonpyrogenic and can be administered by the intravenous, intramuscular, subcutaneous, or intracardiac routes.</Description>
</NDC>
<NDC>
<NDCCode>69918-731-11</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (69918-731-11) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>69918-0731-11</NDC11Code>
<ProductNDC>69918-731</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isoproterenol Hydrochloride</ProprietaryName>
<NonProprietaryName>Isoproterenol Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211237</ApplicationNumber>
<LabelerName>Nordic Pharma, Inc.</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>Active</Status>
<LastUpdate>2024-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isoproterenol hydrochloride injection is indicated: 1 To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output, 2 For bronchospasm occurring during anesthesia.</IndicationAndUsage>
<Description>Isoproterenol hydrochloride, USP is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. The molecular formula is C11H17NO3 HCl. It has a molecular weight of 247.72 and the following structural formula. Isoproterenol hydrochloride, USP is a racemic compound. The pH is adjusted between 2.5 and 4.5 with hydrochloric acid or sodium hydroxide. The sterile solution is nonpyrogenic and can be administered by the intravenous, intramuscular, subcutaneous, or intracardiac routes.</Description>
</NDC>
<NDC>
<NDCCode>69918-735-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (69918-735-10) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>69918-0735-10</NDC11Code>
<ProductNDC>69918-735</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isoproterenol Hydrochloride</ProprietaryName>
<NonProprietaryName>Isoproterenol Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20210801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211237</ApplicationNumber>
<LabelerName>Nordic Pharma, Inc.</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>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isoproterenol hydrochloride injection is indicated: 1 To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output, 2 For bronchospasm occurring during anesthesia.</IndicationAndUsage>
<Description>Isoproterenol hydrochloride, USP is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. The molecular formula is C11H17NO3 HCl. It has a molecular weight of 247.72 and the following structural formula. Isoproterenol hydrochloride, USP is a racemic compound. The pH is adjusted between 2.5 and 4.5 with hydrochloric acid or sodium hydroxide. The sterile solution is nonpyrogenic and can be administered by the intravenous, intramuscular, subcutaneous, or intracardiac routes.</Description>
</NDC>
<NDC>
<NDCCode>69918-735-11</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (69918-735-11) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>69918-0735-11</NDC11Code>
<ProductNDC>69918-735</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isoproterenol Hydrochloride</ProprietaryName>
<NonProprietaryName>Isoproterenol Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211237</ApplicationNumber>
<LabelerName>Nordic Pharma, Inc.</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>Active</Status>
<LastUpdate>2024-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isoproterenol hydrochloride injection is indicated: 1 To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output, 2 For bronchospasm occurring during anesthesia.</IndicationAndUsage>
<Description>Isoproterenol hydrochloride, USP is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. The molecular formula is C11H17NO3 HCl. It has a molecular weight of 247.72 and the following structural formula. Isoproterenol hydrochloride, USP is a racemic compound. The pH is adjusted between 2.5 and 4.5 with hydrochloric acid or sodium hydroxide. The sterile solution is nonpyrogenic and can be administered by the intravenous, intramuscular, subcutaneous, or intracardiac routes.</Description>
</NDC>
<NDC>
<NDCCode>69918-899-10</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (69918-899-10) / 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>69918-0899-10</NDC11Code>
<ProductNDC>69918-899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018938</ApplicationNumber>
<LabelerName>Nordic Pharma, Inc.</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).</IndicationAndUsage>
<Description>Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>69918-899-11</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (69918-899-11) / 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>69918-0899-11</NDC11Code>
<ProductNDC>69918-899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220107</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018938</ApplicationNumber>
<LabelerName>Nordic Pharma, Inc.</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desmopressin acetate injection is a vasopressin analog used for: 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1), 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2), 3 von Willebrand’s disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3).</IndicationAndUsage>
<Description>Desmopressin acetate injection is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate solution for injection is a sterile solution in a 1 mL single-dose ampule: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>14789-901-10</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (14789-901-10) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>14789-0901-10</NDC11Code>
<ProductNDC>14789-901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Procainamide Hydrochloride</ProprietaryName>
<NonProprietaryName>Procainamide Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20071014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206332</ApplicationNumber>
<LabelerName>Nexus Pharmaceuticals LLC</LabelerName>
<SubstanceName>PROCAINAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of procainamide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (see WARNINGSand Boxed Warning.).</IndicationAndUsage>
<Description>Procainamide Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of procainamide hydrochloride in water for injection. Each milliliter of the 2 mL vial contains procainamide hydrochloride 500 mg; methylparaben 1 mg and sodium metabisulfite 1.8 mg added in water for injection. Each milliliter of the 10 mL vial contains procainamide hydrochloride 100 mg; methylparaben 1 mg and sodium metabisulfite 0.8 mg added in water for injection. In both formulations, the solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.0 (4.0 to 6.0). Headspace nitrogen gassed. Procainamide Hydrochloride Injection is intended for intravenous or intramuscular administration. Procainamide hydrochloride, a Group 1A cardiac antiarrhythmic drug, is p-amino-N-[2-(diethylamino) ethyl] benzamide mono- hydrochloride. It has the following structural formula. *(locus for acetylation to N-acetyl procainamide). It differs from procaine which is the p-aminobenzoyl ester of 2-(diethylamino)-ethanol. Procainamide as the free base has a pKa of 9.23; the monohydrochloride is very soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>19515-901-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (19515-901-52) > .5 mL in 1 SYRINGE (19515-901-41)</PackageDescription>
<NDC11Code>19515-0901-52</NDC11Code>
<ProductNDC>19515-901</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Flulaval Quadrivalent</ProprietaryName>
<ProprietaryNameSuffix>2015/2016</ProprietaryNameSuffix>
<NonProprietaryName>Influenza Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125163</ApplicationNumber>
<LabelerName>ID Biomedical Corporation of Quebec</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>23155-901-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (23155-901-10) </PackageDescription>
<NDC11Code>23155-0901-10</NDC11Code>
<ProductNDC>23155-901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074225</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide Tablets USP are a loop diuretic available as 0.5 mg (white to off-white), 1 mg (white to off-white) and 2 mg (white to off-white) tablets for oral administration; each tablet also contains: anhydrous lactose, corn starch, magnesium stearate, microcrystalline cellulose and talc. Chemically, bumetanide, USP is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder. It is slightly soluble in water and soluble in alkaline solutions. It has the following structural formula. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>24208-901-99</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (24208-901-99) * 1 mL in 1 BOTTLE, DROPPER * 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>24208-0901-99</NDC11Code>
<ProductNDC>24208-901</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alaway</ProprietaryName>
<NonProprietaryName>Ketotifen Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20061201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021996</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>31720-901-10</NDCCode>
<PackageDescription>50 mL in 1 TUBE (31720-901-10)</PackageDescription>
<NDC11Code>31720-0901-10</NDC11Code>
<ProductNDC>31720-901</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sephora Perfecting Tinted Moisturizer Light 15 Nude</ProprietaryName>
<ProprietaryNameSuffix>Spf 20</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate And Avobenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>S+</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>3; 7.5; 5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-06-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>31722-901-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (31722-901-10)</PackageDescription>
<NDC11Code>31722-0901-10</NDC11Code>
<ProductNDC>31722-901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel</ProprietaryName>
<NonProprietaryName>Clopidogrel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204165</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clopidogrel is a P2Y12 platelet inhibitor indicated for:. · Acute coronary syndrome. - For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], Clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1). - For patients with ST-elevation myocardial infarction (STEMI), Clopidogrel has been shown to reduce the rate of MI and stroke. (1.1). · Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. (1.2).</IndicationAndUsage>
<Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is freely soluble in methanol, practically insoluble in ether. It has a specific optical rotation of about +56°. Clopidogrel for oral administration is provided as either pink colored, round shaped, biconvex, de-bossed, film coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink colored, modified oval shaped, de-bossed film coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose and hydrogenated castor oil as inactive ingredients. The film coating contains hypromellose, titanium dioxide, polyethylene glycol and red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>37012-901-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (37012-901-10) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>37012-0901-10</NDC11Code>
<ProductNDC>37012-901</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasal</ProprietaryName>
<NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20160803</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Shopko Stores Operating Co., LLC</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43598-901-58</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (43598-901-58) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (43598-901-11) </PackageDescription>
<NDC11Code>43598-0901-58</NDC11Code>
<ProductNDC>43598-901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ertapenem Sodium</ProprietaryName>
<NonProprietaryName>Ertapenem</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20210429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212040</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc.,</LabelerName>
<SubstanceName>ERTAPENEM SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ertapenem for injection and other antibacterial drugs, Ertapenem 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. Treatment. Ertapenem for injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with the following moderate to severe infections caused by susceptible isolates of the designated microorganisms [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Ertapenem for injection is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics. Chemically, Ertapenem for injection is described as [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt. Its molecular weight is 497.50. The empirical formula is C22H24N3O7SNa, and its structural formula is. Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran. Ertapenem for Injection is supplied as sterile lyophilized powder for intravenous infusion after reconstitution with appropriate diluent [see Dosage and Administration (2.7)] and transfer to 50 mL 0.9% Sodium Chloride Injection or for intramuscular injection following reconstitution with 1% lidocaine hydrochloride. Each single-dose vial contains 1 gram ertapenem equivalent to 1.046 grams ertapenem sodium. The sodium content is approximately 137 mg (approximately 6.0 mEq). Each vial of Ertapenem for Injection contains the following inactive ingredients: 175 mg sodium bicarbonate and sodium hydroxide to adjust pH to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>46144-901-10</NDCCode>
<PackageDescription>1000 g in 1 BOTTLE, PLASTIC (46144-901-10)</PackageDescription>
<NDC11Code>46144-0901-10</NDC11Code>
<ProductNDC>46144-901</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ketoprofen</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20121119</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>API Solutions, Inc.</LabelerName>
<SubstanceName>KETOPROFEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>