{
"NDC": [
{
"NDCCode": "0409-7953-30",
"PackageDescription": "24 BAG in 1 CASE (0409-7953-30) > 500 mL in 1 BAG",
"NDC11Code": "00409-7953-30",
"ProductNDC": "0409-7953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19760126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017641",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "20; 30; 600; 310",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-09-05"
},
{
"NDCCode": "0615-7953-39",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (0615-7953-39) ",
"NDC11Code": "00615-7953-39",
"ProductNDC": "0615-7953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitslopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120910",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078169",
"LabelerName": "NCS HealthCare of KY, Inc dba Vangard Labs",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160414",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "68788-7953-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68788-7953-3) ",
"NDC11Code": "68788-7953-03",
"ProductNDC": "68788-7953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212399",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210709",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
},
{
"NDCCode": "0409-7953-02",
"PackageDescription": "24 POUCH in 1 CASE (0409-7953-02) > 1 BAG in 1 POUCH > 250 mL in 1 BAG",
"NDC11Code": "00409-7953-02",
"ProductNDC": "0409-7953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050331",
"EndMarketingDate": "20211001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017641",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
"StrengthNumber": "600; 310; 30; 20",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050331",
"EndMarketingDatePackage": "20210201",
"SamplePackage": "N"
},
{
"NDCCode": "0409-7953-03",
"PackageDescription": "24 POUCH in 1 CASE (0409-7953-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-7953-03",
"ProductNDC": "0409-7953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050331",
"EndMarketingDate": "20211001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017641",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
"StrengthNumber": "600; 310; 30; 20",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050512",
"EndMarketingDatePackage": "20210601",
"SamplePackage": "N"
},
{
"NDCCode": "0409-7953-09",
"PackageDescription": "12 POUCH in 1 CASE (0409-7953-09) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG",
"NDC11Code": "00409-7953-09",
"ProductNDC": "0409-7953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050331",
"EndMarketingDate": "20211001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017641",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
"StrengthNumber": "600; 310; 30; 20",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050512",
"EndMarketingDatePackage": "20211001",
"SamplePackage": "N"
},
{
"NDCCode": "0409-7953-25",
"PackageDescription": "24 BAG in 1 CASE (0409-7953-25) > 250 mL in 1 BAG",
"NDC11Code": "00409-7953-25",
"ProductNDC": "0409-7953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19760126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017641",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "20; 30; 600; 310",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-09-05"
},
{
"NDCCode": "0409-7953-48",
"PackageDescription": "12 BAG in 1 CASE (0409-7953-48) > 1000 mL in 1 BAG",
"NDC11Code": "00409-7953-48",
"ProductNDC": "0409-7953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19760126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017641",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "20; 30; 600; 310",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-09-05"
},
{
"NDCCode": "0990-7953-02",
"PackageDescription": "24 POUCH in 1 CASE (0990-7953-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG",
"NDC11Code": "00990-7953-02",
"ProductNDC": "0990-7953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190624",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017641",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
"StrengthNumber": "600; 310; 30; 20",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190624",
"SamplePackage": "N",
"IndicationAndUsage": "These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.",
"Description": "These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5). Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5). The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
},
{
"NDCCode": "0990-7953-03",
"PackageDescription": "24 POUCH in 1 CASE (0990-7953-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG",
"NDC11Code": "00990-7953-03",
"ProductNDC": "0990-7953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190624",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017641",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
"StrengthNumber": "600; 310; 30; 20",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.",
"Description": "These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5). Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5). The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
},
{
"NDCCode": "0990-7953-09",
"PackageDescription": "12 POUCH in 1 CASE (0990-7953-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG",
"NDC11Code": "00990-7953-09",
"ProductNDC": "0990-7953",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190624",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017641",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
"StrengthNumber": "600; 310; 30; 20",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.",
"Description": "These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5). Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5). The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers."
},
{
"NDCCode": "0220-0409-41",
"PackageDescription": "30 [hp_C] in 1 TUBE (0220-0409-41) ",
"NDC11Code": "00220-0409-41",
"ProductNDC": "0220-0409",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Apis Mellifica",
"NonProprietaryName": "Apis Mellifera",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "APIS MELLIFERA",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/30[hp_C]",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. Box- temporarily relieves symptoms of minor insect stings and bites such as. : 1 pain, 2 itching, 3 swelling."
},
{
"NDCCode": "0220-0409-43",
"PackageDescription": "3 TUBE in 1 BOX (0220-0409-43) / 30 [hp_C] in 1 TUBE",
"NDC11Code": "00220-0409-43",
"ProductNDC": "0220-0409",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Apis Mellifica",
"NonProprietaryName": "Apis Mellifera",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "APIS MELLIFERA",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/30[hp_C]",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220510",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*. Box- temporarily relieves symptoms of minor insect stings and bites such as. : 1 pain, 2 itching, 3 swelling."
},
{
"NDCCode": "0409-0012-30",
"PackageDescription": "30 POUCH in 1 CASE (0409-0012-30) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-0012-02) ",
"NDC11Code": "00409-0012-30",
"ProductNDC": "0409-0012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018916",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "5000",
"StrengthUnit": "[USP'U]/100mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230227",
"SamplePackage": "N",
"IndicationAndUsage": "HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION is indicated for: 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism;, 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation;, 3 Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);, 4 Prevention of clotting in arterial and cardiac surgery;, 5 Prophylaxis and treatment of peripheral arterial embolism;, 6 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.",
"Description": "Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-Sulfated O-Sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of Heparin Sodium (representative subunits). HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION is a sterile preparation of heparin sodium (derived from porcine intestinal mucosa) for intravenous administration. It contains no bacteriostatic or antimicrobial agent or added buffer. The solution may contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH range is 6.1 (5.0 – 7.5) and the osmolarity mOsmol/L (calc.) is 155. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Each mL of the 50 USP Units per mL preparations contains: 50 USP Units of heparin sodium, 4.5 mg sodium chloride and 0.1 mg edetate disodium, anhydrous added as a stabilizer. Each mL of the 100 USP Units per mL preparations contains: 100 USP Units of heparin sodium, 4.5 mg sodium chloride and 0.1 mg edetate disodium, anhydrous added as a stabilizer."
},
{
"NDCCode": "0409-1036-30",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1036-30) > 30 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-1036-30",
"ProductNDC": "0409-1036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbocaine",
"NonProprietaryName": "Mepivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION",
"StartMarketingDate": "20060323",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012250",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MEPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20060323",
"SamplePackage": "N"
},
{
"NDCCode": "0409-1041-30",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1041-30) > 30 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-1041-30",
"ProductNDC": "0409-1041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbocaine",
"NonProprietaryName": "Mepivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION",
"StartMarketingDate": "20060428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012250",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MEPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20060428",
"SamplePackage": "N"
},
{
"NDCCode": "0409-1158-01",
"PackageDescription": "5 AMPULE in 1 CARTON (0409-1158-01) > 30 mL in 1 AMPULE",
"NDC11Code": "00409-1158-01",
"ProductNDC": "0409-1158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine Hydrochloride",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL",
"StartMarketingDate": "19870303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070586",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0409-1159-02",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-19) ",
"NDC11Code": "00409-1159-02",
"ProductNDC": "0409-1159",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine Hydrochloride",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20050506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070583",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050815",
"SamplePackage": "N",
"IndicationAndUsage": "Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for Bupivacaine Hydrochloride and Epinephrine Injection is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine hydrochloride with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple-dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. Epinephrine is a vasoconstrictor. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg, or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg, or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Bupivacaine Hydrochloride and Epinephrine Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.005 mg of epinephrine, with sodium chloride for isotonicity, 0.1 mg sodium metabisulfite as antioxidant, and 0.1 mg edetate calcium disodium anhydrous as stabilizer. The pH of these solutions is adjusted to between 3.3 and 5.5 with sodium hydroxide or hydrochloric acid. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of Bupivacaine Hydrochloride and Epinephrine Injection [0.5% (5 mg/mL) of bupivacaine] at 25 ºC is 1.007."
},
{
"NDCCode": "0409-1159-10",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-09) ",
"NDC11Code": "00409-1159-10",
"ProductNDC": "0409-1159",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine Hydrochloride",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20150811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070583",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150811",
"SamplePackage": "N",
"IndicationAndUsage": "Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use. Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].",
"Description": "Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for Bupivacaine Hydrochloride and Epinephrine Injection is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine hydrochloride with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple-dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. Epinephrine is a vasoconstrictor. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg, or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg, or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Bupivacaine Hydrochloride and Epinephrine Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.005 mg of epinephrine, with sodium chloride for isotonicity, 0.1 mg sodium metabisulfite as antioxidant, and 0.1 mg edetate calcium disodium anhydrous as stabilizer. The pH of these solutions is adjusted to between 3.3 and 5.5 with sodium hydroxide or hydrochloric acid. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of Bupivacaine Hydrochloride and Epinephrine Injection [0.5% (5 mg/mL) of bupivacaine] at 25°C is 1.007."
},
{
"NDCCode": "0409-1161-01",
"PackageDescription": "5 AMPULE in 1 CARTON (0409-1161-01) > 30 mL in 1 AMPULE (0409-1161-18) ",
"NDC11Code": "00409-1161-01",
"ProductNDC": "0409-1161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine Hydrochloride",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20041130",
"EndMarketingDate": "20180601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070609",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20041130",
"EndMarketingDatePackage": "20180601",
"SamplePackage": "N"
},
{
"NDCCode": "0409-1162-02",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1162-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1162-19) ",
"NDC11Code": "00409-1162-02",
"ProductNDC": "0409-1162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine Hydrochloride",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20051122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070584",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20051122",
"SamplePackage": "N",
"IndicationAndUsage": "Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for Bupivacaine Hydrochloride and Epinephrine Injection is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine hydrochloride with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple-dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. Epinephrine is a vasoconstrictor. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg, or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg, or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Bupivacaine Hydrochloride and Epinephrine Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.005 mg of epinephrine, with sodium chloride for isotonicity, 0.1 mg sodium metabisulfite as antioxidant, and 0.1 mg edetate calcium disodium anhydrous as stabilizer. The pH of these solutions is adjusted to between 3.3 and 5.5 with sodium hydroxide or hydrochloric acid. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of Bupivacaine Hydrochloride and Epinephrine Injection [0.5% (5 mg/mL) of bupivacaine] at 25 ºC is 1.007."
},
{
"NDCCode": "0409-1162-10",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1162-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1162-09) ",
"NDC11Code": "00409-1162-10",
"ProductNDC": "0409-1162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine Hydrochloride",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20170207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070584",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170207",
"SamplePackage": "N"
},
{
"NDCCode": "0409-1165-02",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1165-19) ",
"NDC11Code": "00409-1165-02",
"ProductNDC": "0409-1165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupivacaine Hydrochloride",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; RETROBULBAR",
"StartMarketingDate": "20050608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070585",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050608",
"SamplePackage": "N",
"IndicationAndUsage": "Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for Bupivacaine Hydrochloride and Epinephrine Injection is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine hydrochloride with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple-dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. Epinephrine is a vasoconstrictor. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg, or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg, or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Bupivacaine Hydrochloride and Epinephrine Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.005 mg of epinephrine, with sodium chloride for isotonicity, 0.1 mg sodium metabisulfite as antioxidant, and 0.1 mg edetate calcium disodium anhydrous as stabilizer. The pH of these solutions is adjusted to between 3.3 and 5.5 with sodium hydroxide or hydrochloric acid. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of Bupivacaine Hydrochloride and Epinephrine Injection [0.5% (5 mg/mL) of bupivacaine] at 25 ºC is 1.007."
},
{
"NDCCode": "0409-1176-30",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1176-30) / 1 mL in 1 CARTRIDGE (0409-1176-03) ",
"NDC11Code": "00409-1176-30",
"ProductNDC": "0409-1176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Demerol",
"NonProprietaryName": "Meperidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050825",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021171",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050825",
"SamplePackage": "N",
"IndicationAndUsage": "DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C."
},
{
"NDCCode": "0409-1178-30",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1178-30) / 1 mL in 1 CARTRIDGE (0409-1178-03) ",
"NDC11Code": "00409-1178-30",
"ProductNDC": "0409-1178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Demerol",
"NonProprietaryName": "Meperidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050913",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021171",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050913",
"SamplePackage": "N",
"IndicationAndUsage": "DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C."
},
{
"NDCCode": "0409-1179-30",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1179-30) / 1 mL in 1 CARTRIDGE (0409-1179-03) ",
"NDC11Code": "00409-1179-30",
"ProductNDC": "0409-1179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Demerol",
"NonProprietaryName": "Meperidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20051012",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021171",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20051012",
"SamplePackage": "N",
"IndicationAndUsage": "DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C."
},
{
"NDCCode": "0409-1181-30",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-1181-30) / 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-1181-30",
"ProductNDC": "0409-1181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Demerol",
"NonProprietaryName": "Meperidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20060224",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021171",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MEPERIDINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060224",
"SamplePackage": "N",
"IndicationAndUsage": "DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C."
},
{
"NDCCode": "0409-1219-25",
"PackageDescription": "25 CARTON in 1 CASE (0409-1219-25) > 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1219-30) > 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-1219-25",
"ProductNDC": "0409-1219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20140409",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070257",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Antagonist [EPC],Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140409",
"SamplePackage": "N"
},
{
"NDCCode": "0409-1261-30",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1261-30) > 1 mL in 1 CARTRIDGE",
"NDC11Code": "00409-1261-30",
"ProductNDC": "0409-1261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970609",
"EndMarketingDate": "20140301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "0409-1312-30",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1312-30) / 1 mL in 1 CARTRIDGE (0409-1312-03) ",
"NDC11Code": "00409-1312-30",
"ProductNDC": "0409-1312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200403",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. ."
}
]
}
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<NDCList>
<NDC>
<NDCCode>0409-7953-30</NDCCode>
<PackageDescription>24 BAG in 1 CASE (0409-7953-30) > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-7953-30</NDC11Code>
<ProductNDC>0409-7953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19760126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017641</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>20; 30; 600; 310</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-09-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0615-7953-39</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (0615-7953-39) </PackageDescription>
<NDC11Code>00615-7953-39</NDC11Code>
<ProductNDC>0615-7953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitslopram</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20120910</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078169</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, Inc dba Vangard Labs</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160414</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68788-7953-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68788-7953-3) </PackageDescription>
<NDC11Code>68788-7953-03</NDC11Code>
<ProductNDC>68788-7953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212399</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>0409-7953-02</NDCCode>
<PackageDescription>24 POUCH in 1 CASE (0409-7953-02) > 1 BAG in 1 POUCH > 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-7953-02</NDC11Code>
<ProductNDC>0409-7953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers</ProprietaryName>
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<StartMarketingDate>20050331</StartMarketingDate>
<EndMarketingDate>20211001</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017641</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>600; 310; 30; 20</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050331</StartMarketingDatePackage>
<EndMarketingDatePackage>20210201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-7953-03</NDCCode>
<PackageDescription>24 POUCH in 1 CASE (0409-7953-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-7953-03</NDC11Code>
<ProductNDC>0409-7953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050331</StartMarketingDate>
<EndMarketingDate>20211001</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017641</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>600; 310; 30; 20</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050512</StartMarketingDatePackage>
<EndMarketingDatePackage>20210601</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-7953-09</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-7953-09) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-7953-09</NDC11Code>
<ProductNDC>0409-7953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050331</StartMarketingDate>
<EndMarketingDate>20211001</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017641</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>600; 310; 30; 20</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050512</StartMarketingDatePackage>
<EndMarketingDatePackage>20211001</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-7953-25</NDCCode>
<PackageDescription>24 BAG in 1 CASE (0409-7953-25) > 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-7953-25</NDC11Code>
<ProductNDC>0409-7953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19760126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017641</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>20; 30; 600; 310</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-09-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-7953-48</NDCCode>
<PackageDescription>12 BAG in 1 CASE (0409-7953-48) > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-7953-48</NDC11Code>
<ProductNDC>0409-7953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19760126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017641</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>20; 30; 600; 310</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-09-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0990-7953-02</NDCCode>
<PackageDescription>24 POUCH in 1 CASE (0990-7953-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7953-02</NDC11Code>
<ProductNDC>0990-7953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190624</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017641</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>600; 310; 30; 20</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.</IndicationAndUsage>
<Description>These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5). Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5). The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0990-7953-03</NDCCode>
<PackageDescription>24 POUCH in 1 CASE (0990-7953-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7953-03</NDC11Code>
<ProductNDC>0990-7953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190624</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017641</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>600; 310; 30; 20</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.</IndicationAndUsage>
<Description>These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5). Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5). The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0990-7953-09</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0990-7953-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7953-09</NDC11Code>
<ProductNDC>0990-7953</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190624</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017641</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>600; 310; 30; 20</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.</IndicationAndUsage>
<Description>These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5). Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5). The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2 H2O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0220-0409-41</NDCCode>
<PackageDescription>30 [hp_C] in 1 TUBE (0220-0409-41) </PackageDescription>
<NDC11Code>00220-0409-41</NDC11Code>
<ProductNDC>0220-0409</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Apis Mellifica</ProprietaryName>
<NonProprietaryName>Apis Mellifera</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>APIS MELLIFERA</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/30[hp_C]</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses*. Box- temporarily relieves symptoms of minor insect stings and bites such as. : 1 pain, 2 itching, 3 swelling.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0220-0409-43</NDCCode>
<PackageDescription>3 TUBE in 1 BOX (0220-0409-43) / 30 [hp_C] in 1 TUBE</PackageDescription>
<NDC11Code>00220-0409-43</NDC11Code>
<ProductNDC>0220-0409</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Apis Mellifica</ProprietaryName>
<NonProprietaryName>Apis Mellifera</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>APIS MELLIFERA</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/30[hp_C]</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses*. Box- temporarily relieves symptoms of minor insect stings and bites such as. : 1 pain, 2 itching, 3 swelling.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0409-0012-30</NDCCode>
<PackageDescription>30 POUCH in 1 CASE (0409-0012-30) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-0012-02) </PackageDescription>
<NDC11Code>00409-0012-30</NDC11Code>
<ProductNDC>0409-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018916</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>5000</StrengthNumber>
<StrengthUnit>[USP'U]/100mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION is indicated for: 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism;, 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation;, 3 Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);, 4 Prevention of clotting in arterial and cardiac surgery;, 5 Prophylaxis and treatment of peripheral arterial embolism;, 6 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.</IndicationAndUsage>
<Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-Sulfated O-Sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucoronic acid). Structure of Heparin Sodium (representative subunits). HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION is a sterile preparation of heparin sodium (derived from porcine intestinal mucosa) for intravenous administration. It contains no bacteriostatic or antimicrobial agent or added buffer. The solution may contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH range is 6.1 (5.0 – 7.5) and the osmolarity mOsmol/L (calc.) is 155. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Each mL of the 50 USP Units per mL preparations contains: 50 USP Units of heparin sodium, 4.5 mg sodium chloride and 0.1 mg edetate disodium, anhydrous added as a stabilizer. Each mL of the 100 USP Units per mL preparations contains: 100 USP Units of heparin sodium, 4.5 mg sodium chloride and 0.1 mg edetate disodium, anhydrous added as a stabilizer.</Description>
</NDC>
<NDC>
<NDCCode>0409-1036-30</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1036-30) > 30 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-1036-30</NDC11Code>
<ProductNDC>0409-1036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbocaine</ProprietaryName>
<NonProprietaryName>Mepivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION</RouteName>
<StartMarketingDate>20060323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012250</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MEPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-1041-30</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1041-30) > 30 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-1041-30</NDC11Code>
<ProductNDC>0409-1041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbocaine</ProprietaryName>
<NonProprietaryName>Mepivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION</RouteName>
<StartMarketingDate>20060428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012250</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MEPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-1158-01</NDCCode>
<PackageDescription>5 AMPULE in 1 CARTON (0409-1158-01) > 30 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00409-1158-01</NDC11Code>
<ProductNDC>0409-1158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL</RouteName>
<StartMarketingDate>19870303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070586</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-1159-02</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-19) </PackageDescription>
<NDC11Code>00409-1159-02</NDC11Code>
<ProductNDC>0409-1159</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20050506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070583</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for Bupivacaine Hydrochloride and Epinephrine Injection is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine hydrochloride with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple-dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. Epinephrine is a vasoconstrictor. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg, or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg, or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Bupivacaine Hydrochloride and Epinephrine Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.005 mg of epinephrine, with sodium chloride for isotonicity, 0.1 mg sodium metabisulfite as antioxidant, and 0.1 mg edetate calcium disodium anhydrous as stabilizer. The pH of these solutions is adjusted to between 3.3 and 5.5 with sodium hydroxide or hydrochloric acid. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of Bupivacaine Hydrochloride and Epinephrine Injection [0.5% (5 mg/mL) of bupivacaine] at 25 ºC is 1.007.</Description>
</NDC>
<NDC>
<NDCCode>0409-1159-10</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-09) </PackageDescription>
<NDC11Code>00409-1159-10</NDC11Code>
<ProductNDC>0409-1159</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20150811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070583</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use. Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].</IndicationAndUsage>
<Description>Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for Bupivacaine Hydrochloride and Epinephrine Injection is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine hydrochloride with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple-dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. Epinephrine is a vasoconstrictor. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg, or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg, or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Bupivacaine Hydrochloride and Epinephrine Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.005 mg of epinephrine, with sodium chloride for isotonicity, 0.1 mg sodium metabisulfite as antioxidant, and 0.1 mg edetate calcium disodium anhydrous as stabilizer. The pH of these solutions is adjusted to between 3.3 and 5.5 with sodium hydroxide or hydrochloric acid. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of Bupivacaine Hydrochloride and Epinephrine Injection [0.5% (5 mg/mL) of bupivacaine] at 25°C is 1.007.</Description>
</NDC>
<NDC>
<NDCCode>0409-1161-01</NDCCode>
<PackageDescription>5 AMPULE in 1 CARTON (0409-1161-01) > 30 mL in 1 AMPULE (0409-1161-18) </PackageDescription>
<NDC11Code>00409-1161-01</NDC11Code>
<ProductNDC>0409-1161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20041130</StartMarketingDate>
<EndMarketingDate>20180601</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070609</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20041130</StartMarketingDatePackage>
<EndMarketingDatePackage>20180601</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-1162-02</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1162-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1162-19) </PackageDescription>
<NDC11Code>00409-1162-02</NDC11Code>
<ProductNDC>0409-1162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20051122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070584</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for Bupivacaine Hydrochloride and Epinephrine Injection is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine hydrochloride with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple-dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. Epinephrine is a vasoconstrictor. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg, or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg, or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Bupivacaine Hydrochloride and Epinephrine Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.005 mg of epinephrine, with sodium chloride for isotonicity, 0.1 mg sodium metabisulfite as antioxidant, and 0.1 mg edetate calcium disodium anhydrous as stabilizer. The pH of these solutions is adjusted to between 3.3 and 5.5 with sodium hydroxide or hydrochloric acid. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of Bupivacaine Hydrochloride and Epinephrine Injection [0.5% (5 mg/mL) of bupivacaine] at 25 ºC is 1.007.</Description>
</NDC>
<NDC>
<NDCCode>0409-1162-10</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1162-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1162-09) </PackageDescription>
<NDC11Code>00409-1162-10</NDC11Code>
<ProductNDC>0409-1162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20170207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070584</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-1165-02</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1165-19) </PackageDescription>
<NDC11Code>00409-1165-02</NDC11Code>
<ProductNDC>0409-1165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; RETROBULBAR</RouteName>
<StartMarketingDate>20050608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070585</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride Injection (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for Bupivacaine Hydrochloride and Epinephrine Injection is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. Bupivacaine hydrochloride with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple-dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. Epinephrine is a vasoconstrictor. It has the following structural formula. Bupivacaine Hydrochloride Injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg, or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg, or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Bupivacaine Hydrochloride and Epinephrine Injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.005 mg of epinephrine, with sodium chloride for isotonicity, 0.1 mg sodium metabisulfite as antioxidant, and 0.1 mg edetate calcium disodium anhydrous as stabilizer. The pH of these solutions is adjusted to between 3.3 and 5.5 with sodium hydroxide or hydrochloric acid. For the multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of Bupivacaine Hydrochloride and Epinephrine Injection [0.5% (5 mg/mL) of bupivacaine] at 25 ºC is 1.007.</Description>
</NDC>
<NDC>
<NDCCode>0409-1176-30</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1176-30) / 1 mL in 1 CARTRIDGE (0409-1176-03) </PackageDescription>
<NDC11Code>00409-1176-30</NDC11Code>
<ProductNDC>0409-1176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Demerol</ProprietaryName>
<NonProprietaryName>Meperidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050825</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021171</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C.</Description>
</NDC>
<NDC>
<NDCCode>0409-1178-30</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1178-30) / 1 mL in 1 CARTRIDGE (0409-1178-03) </PackageDescription>
<NDC11Code>00409-1178-30</NDC11Code>
<ProductNDC>0409-1178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Demerol</ProprietaryName>
<NonProprietaryName>Meperidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050913</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021171</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C.</Description>
</NDC>
<NDC>
<NDCCode>0409-1179-30</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1179-30) / 1 mL in 1 CARTRIDGE (0409-1179-03) </PackageDescription>
<NDC11Code>00409-1179-30</NDC11Code>
<ProductNDC>0409-1179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Demerol</ProprietaryName>
<NonProprietaryName>Meperidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20051012</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021171</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C.</Description>
</NDC>
<NDC>
<NDCCode>0409-1181-30</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0409-1181-30) / 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00409-1181-30</NDC11Code>
<ProductNDC>0409-1181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Demerol</ProprietaryName>
<NonProprietaryName>Meperidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20060224</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021171</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MEPERIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. DEMEROL Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride as the active pharmaceutical ingredient. Meperidine hydrochloride chemical name is 4‑Piperidinecarboxylic acid, 1‑methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.79 g/mol. Its molecular formula is C15H21NO2·HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C, and it is readily soluble in water. DEMEROL (meperidine hydrochloride injection) is available as. Single-dose CarpujectTM cartridge with Luer Lock for the Carpuject Syringe System: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. Each mL of Single-dose cartridge contains 25 mg, 50 mg, 75 mg or 100 mg of meperidine hydrochloride USP (equivalent to 21.79 mg, 43.58 mg, 65.36 mg or 87.15 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) strength. Each mL of vial contains 50 mg of meperidine hydrochloride USP (equivalent to 43.58 mg of meperidine), 1 mg of meta-cresol USP, as a preservative, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Single-dose NexJect Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL strengths. Each mL contains 25 mg or 50 mg of meperidine hydrochloride USP (equivalent to 21.79 mg or 43.58 mg of meperidine), respectively, and sodium hydroxide NF, and hydrochloric acid NF as pH adjusters, in water for injection. Only the 25 mg strength contains 3.8 mg of sodium chloride USP as isotonicity agent. The pH of DEMEROL (meperidine hydrochloride injection) solutions is between 3.5 and 6.0. DEMEROL (meperidine hydrochloride injection) 5 percent solution has a specific gravity of 1.0086 at 20°C, and the 10 percent solution has a specific gravity of 1.0165 at 20°C.</Description>
</NDC>
<NDC>
<NDCCode>0409-1219-25</NDCCode>
<PackageDescription>25 CARTON in 1 CASE (0409-1219-25) > 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1219-30) > 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00409-1219-25</NDC11Code>
<ProductNDC>0409-1219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20140409</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070257</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC],Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-1261-30</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1261-30) > 1 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00409-1261-30</NDC11Code>
<ProductNDC>0409-1261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970609</StartMarketingDate>
<EndMarketingDate>20140301</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-1312-30</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1312-30) / 1 mL in 1 CARTRIDGE (0409-1312-03) </PackageDescription>
<NDC11Code>00409-1312-30</NDC11Code>
<ProductNDC>0409-1312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200403</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. .</Description>
</NDC>
</NDCList>