RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "14537-817-75",
      "PackageDescription": "12 BAG in 1 CARTON (14537-817-75)  / 750 mL in 1 BAG",
      "NDC11Code": "14537-0817-75",
      "ProductNDC": "14537-817",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acd",
      "ProprietaryNameSuffix": "A",
      "NonProprietaryName": "Citric Acid Monohydrate, Dextrose Monohydrate, And Trisodium Citrate Dihydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20020225",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "BA010228",
      "LabelerName": "Terumo BCT, Ltd.",
      "SubstanceName": "CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".8; 2.45; 2.2",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020225",
      "SamplePackage": "N",
      "IndicationAndUsage": "ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant for blood collection for use only with apheresis devices. [See Dosage and Administration (2).].",
      "Description": "ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A contains: (%w/v) Citric Acid, Monohydrate 0.8 g; Dextrose Monohydrate 2.45 g; Sodium Citrate Dihydrate 2.2 g; and Water for Injection. The polyolefin bag is not made with natural rubber latex or PVC. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The solution contact layer is an elasticized polyolefin. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary."
    },
    {
      "NDCCode": "14537-967-75",
      "PackageDescription": "12 BAG in 1 CASE (14537-967-75)  / 750 mL in 1 BAG",
      "NDC11Code": "14537-0967-75",
      "ProductNDC": "14537-967",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acd",
      "ProprietaryNameSuffix": "A",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Citrate, And Citric Acid Monohydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20020225",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "BA010228",
      "LabelerName": "Terumo BCT Ltd",
      "SubstanceName": "CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE, UNSPECIFIED FORM",
      "StrengthNumber": ".8; 2.45; 2.2",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020225",
      "SamplePackage": "N",
      "Description": "Sterile. Non-pyrogenic. Do not use unless the solution is clear and the container is intact. Rx Only. Single use container. For use only with apheresis devices. See apheresis device operator's manual for complete instructions."
    },
    {
      "NDCCode": "16714-817-01",
      "PackageDescription": "10 CAPSULE in 1 CARTON (16714-817-01) ",
      "NDC11Code": "16714-0817-01",
      "ProductNDC": "16714-817",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oseltamivir Phosphate",
      "NonProprietaryName": "Oseltamivir Phosphate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180903",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209438",
      "LabelerName": "NorthStar RxLLC",
      "SubstanceName": "OSELTAMIVIR PHOSPHATE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180903",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oseltamivir phosphate  is an influenza neuraminidase inhibitor (NAI) indicated for:  Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1)  Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use:   Not a substitute for annual influenza vaccination. (1.3)  Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3)  Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).",
      "Description": "Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as:  Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch.  Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:."
    },
    {
      "NDCCode": "50268-817-15",
      "PackageDescription": "50 BLISTER PACK in 1 BOX (50268-817-15)  / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-817-11) ",
      "NDC11Code": "50268-0817-15",
      "ProductNDC": "50268-817",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Venlafaxine Hydrochloride",
      "NonProprietaryName": "Venlafaxine Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210427",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203332",
      "LabelerName": "AvPAK",
      "SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
      "StrengthNumber": "37.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-05-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20210427",
      "SamplePackage": "N",
      "Description": "Venlafaxine Hydrochloride Extended-release Capsules, USP for once-a-day oral administration that contains venlafaxine hydrochloride a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethylcellulose, hypromellose and sugar spheres. The empty hard gelatin capsule shells contain gelatin and titanium dioxide. The 37.5 mg capsules also contain iron oxide black. The 75 mg capsules also contain FD&C red No. 3 and FD&C yellow No. 6. The 150 mg capsules also contain iron oxide red and iron oxide yellow. The 37.5 mg, 75 mg and 150 mg capsules are imprinted with black and grey ink which contains iron oxide black, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Grey ink also contains titanium dioxide."
    },
    {
      "NDCCode": "55700-817-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (55700-817-30) ",
      "NDC11Code": "55700-0817-30",
      "ProductNDC": "55700-817",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191108",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208677",
      "LabelerName": "Quality Care Products, LLC",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20191108",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin capsules are indicated for.  Management of neuropathic pain associated with diabetic peripheral neuropathy.  Management of postherpetic neuralgia.  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older.  Management of fibromyalgia.  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide."
    },
    {
      "NDCCode": "55700-817-60",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE (55700-817-60) ",
      "NDC11Code": "55700-0817-60",
      "ProductNDC": "55700-817",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191108",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208677",
      "LabelerName": "Quality Care Products, LLC",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20191108",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin capsules are indicated for.  Management of neuropathic pain associated with diabetic peripheral neuropathy.  Management of postherpetic neuralgia.  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older.  Management of fibromyalgia.  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide."
    },
    {
      "NDCCode": "55700-817-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (55700-817-90) ",
      "NDC11Code": "55700-0817-90",
      "ProductNDC": "55700-817",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pregabalin",
      "NonProprietaryName": "Pregabalin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191108",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208677",
      "LabelerName": "Quality Care Products, LLC",
      "SubstanceName": "PREGABALIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20191108",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pregabalin capsules are indicated for.  Management of neuropathic pain associated with diabetic peripheral neuropathy.  Management of postherpetic neuralgia.  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older.  Management of fibromyalgia.  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
      "Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide."
    },
    {
      "NDCCode": "14537-089-40",
      "PackageDescription": "40 BAG in 1 BOX (14537-089-40)  / 100 mL in 1 BAG",
      "NDC11Code": "14537-0089-40",
      "ProductNDC": "14537-089",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "INJECTION",
      "StartMarketingDate": "20200626",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Terumo BCT Ltd.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "11-JAN-23"
    },
    {
      "NDCCode": "14537-091-40",
      "PackageDescription": "40 BAG in 1 BOX (14537-091-40)  / 100 mL in 1 BAG",
      "NDC11Code": "14537-0091-40",
      "ProductNDC": "14537-091",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "INJECTION",
      "StartMarketingDate": "20200626",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Terumo BCT Ltd.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "11-JAN-23"
    },
    {
      "NDCCode": "14537-092-40",
      "PackageDescription": "40 BAG in 1 BOX (14537-092-40)  / 100 mL in 1 BAG",
      "NDC11Code": "14537-0092-40",
      "ProductNDC": "14537-092",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "INJECTION",
      "StartMarketingDate": "20200626",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Terumo BCT Ltd.",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "11-JAN-23"
    },
    {
      "NDCCode": "14537-093-50",
      "PackageDescription": "50 BAG in 1 BOX (14537-093-50)  / 50 mL in 1 BAG",
      "NDC11Code": "14537-0093-50",
      "ProductNDC": "14537-093",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20210326",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Terumo BCT Ltd.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "meq/50mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "11-JAN-23"
    },
    {
      "NDCCode": "14537-094-40",
      "PackageDescription": "40 BAG in 1 BOX (14537-094-40)  / 100 mL in 1 BAG",
      "NDC11Code": "14537-0094-40",
      "ProductNDC": "14537-094",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20210326",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Terumo BCT Ltd.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "meq/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "11-JAN-23"
    },
    {
      "NDCCode": "14537-095-50",
      "PackageDescription": "50 BAG in 1 BOX (14537-095-50)  / 50 mL in 1 BAG",
      "NDC11Code": "14537-0095-50",
      "ProductNDC": "14537-095",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20210326",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Terumo BCT Ltd.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "meq/50mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "11-JAN-23"
    },
    {
      "NDCCode": "14537-096-40",
      "PackageDescription": "40 BAG in 1 BOX (14537-096-40)  / 100 mL in 1 BAG",
      "NDC11Code": "14537-0096-40",
      "ProductNDC": "14537-096",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20210326",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Terumo BCT Ltd.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "meq/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "11-JAN-23"
    },
    {
      "NDCCode": "14537-097-40",
      "PackageDescription": "40 BAG in 1 BOX (14537-097-40)  / 100 mL in 1 BAG",
      "NDC11Code": "14537-0097-40",
      "ProductNDC": "14537-097",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20210326",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Terumo BCT Ltd.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "meq/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "11-JAN-23"
    },
    {
      "NDCCode": "14537-102-20",
      "PackageDescription": "20 BAG in 1 BOX (14537-102-20)  / 250 mL in 1 BAG",
      "NDC11Code": "14537-0102-20",
      "ProductNDC": "14537-102",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Tirofiban Hydrochloride",
      "DosageFormName": "SOLUTION",
      "StartMarketingDate": "20230608",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "TERUMO BCT LTD",
      "SubstanceName": "TIROFIBAN HYDROCHLORIDE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/250mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "08-JUN-23"
    },
    {
      "NDCCode": "14537-115-08",
      "PackageDescription": "30 BAG in 1 BOX (14537-115-08)  / 100 mL in 1 BAG",
      "NDC11Code": "14537-0115-08",
      "ProductNDC": "14537-115",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Tranexamic Acid",
      "DosageFormName": "SOLUTION",
      "StartMarketingDate": "20230314",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "TERUMO BCT LTD",
      "SubstanceName": "TRANEXAMIC ACID",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "14-MAR-23"
    },
    {
      "NDCCode": "14537-115-30",
      "PackageDescription": "30 BAG in 1 BOX (14537-115-30)  / 100 mL in 1 BAG",
      "NDC11Code": "14537-0115-30",
      "ProductNDC": "14537-115",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Tranexamic Acid",
      "DosageFormName": "SOLUTION",
      "StartMarketingDate": "20230314",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "TERUMO BCT LTD",
      "SubstanceName": "TRANEXAMIC ACID",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "01-NOV-23"
    },
    {
      "NDCCode": "14537-408-50",
      "PackageDescription": "18 CONTAINER in 1 CASE (14537-408-50)  / 500 mL in 1 CONTAINER",
      "NDC11Code": "14537-0408-50",
      "ProductNDC": "14537-408",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isoplate",
      "NonProprietaryName": "Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate, Monobasic",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20130305",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN090067",
      "LabelerName": "Terumo BCT Ltd.",
      "SubstanceName": "MAGNESIUM CHLORIDE; MONOBASIC POTASSIUM PHOSPHATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM",
      "StrengthNumber": ".03; .00082; .037; .37; .53; .5; .008",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], 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], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130305",
      "SamplePackage": "N",
      "IndicationAndUsage": "ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic solution to replace a portion of the plasma to store Platelets Pheresis Platelet Additive Solution (PAS) Added Leukocytes Reduced products collected using a hyperconcentrated collection on Terumo BCT's Trima Accel system [See Dosage and Administration (2).]. Platelets Pheresis PAS Added Leukocytes Reduced products are stored in a mix of 65% ISOPLATE SOLUTION and 35% plasma. Platelets in the solution can be stored at a concentration range of 0.7 to 2.1 × 106/µL for up to 5 days at 20-24 °C with continuous agitation in the Terumo BCT ELP bag [citrated polyvinyl chloride (PVC)] [See Clinical Studies (14).].",
      "Description": "ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic solution designed to replace a proportion of the plasma used in the storage of Platelet Pheresis, Leukocytes Reduced PAS products collected using a hyperconcentrated collection on Terumo BCT's Trima Accel system. The solution is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ISOPLATE SOLUTION contains: Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g; Sodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 g; Magnesium Chloride Hexahydrate USP 0.03 g; Dibasic Sodium Phosphate Dihydrate USP 0.008 g; Monobasic Potassium Phosphate NF 0.00082 g; in Water for Injection USP. pH may be adjusted with glacial Acetic Acid USP or Sodium Hydroxide NF pH: 7.4 (7.0-7.8). Concentration of Electrolytes (mEq/liter): Sodium 141; Potassium 5; Magnesium 3; Chloride 98; Phosphate (HPO=4 ) 1 (0.5 mmole P/liter); Acetate (CH3COO–) 27; Gluconate (HOCH2(CHOH)4COO–) 23. The polyolefin bag is not made with natural rubber latex or PVC. Di(2-ethylhexyl)phthalate (DEHP) is present only in sterile dock tube. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The solution contact layer is an elasticized polyolefin. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary."
    },
    {
      "NDCCode": "14537-815-50",
      "PackageDescription": "18 BAG in 1 CARTON (14537-815-50)  / 500 mL in 1 BAG",
      "NDC11Code": "14537-0815-50",
      "ProductNDC": "14537-815",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acd",
      "ProprietaryNameSuffix": "A",
      "NonProprietaryName": "Citric Acid Monohydrate, Dextrose Monohydrate, And Trisodium Citrate Dihydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20020225",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "BA010228",
      "LabelerName": "Terumo BCT, Ltd.",
      "SubstanceName": "CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".8; 2.45; 2.2",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020225",
      "SamplePackage": "N",
      "IndicationAndUsage": "ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant for blood collection for use only with apheresis devices. [See Dosage and Administration (2).].",
      "Description": "ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A contains: (%w/v) Citric Acid, Monohydrate 0.8 g; Dextrose Monohydrate 2.45 g; Sodium Citrate Dihydrate 2.2 g; and Water for Injection. The polyolefin bag is not made with natural rubber latex or PVC. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The solution contact layer is an elasticized polyolefin. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary."
    },
    {
      "NDCCode": "14537-820-03",
      "PackageDescription": "50 POUCH in 1 CASE (14537-820-03)  / 1 BAG in 1 POUCH (14537-820-01)  / 50 mL in 1 BAG (14537-820-00) ",
      "NDC11Code": "14537-0820-03",
      "ProductNDC": "14537-820",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Anticoagulant Citrate Dextrose (acd-a)",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Citrate, Unspecified Form, And Citric Acid Monohydrate",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20230718",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "BA110057",
      "LabelerName": "Terumo BCT, Ltd",
      "SubstanceName": "CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE, UNSPECIFIED FORM",
      "StrengthNumber": ".08; .245; .22",
      "StrengthUnit": "g/10mL; g/10mL; g/10mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230718",
      "SamplePackage": "N",
      "IndicationAndUsage": "ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. [See Dosage and Administration (2).].",
      "Description": "ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is designed to be added to blood products collected for extracorporeal processing, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal processing set. The content of the solution bag is considered sterile. This product has a sterile fluid path only. The clear overwrap is not considered a sterile barrier. The solution is non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A contains: (%w/v) Citric Acid, Monohydrate 0.8 g; Dextrose Monohydrate 2.45 g; Sodium Citrate Dihydrate 2.2 g; and Water for Injection. The solution bag is not made with natural rubber latex or PVC. The solution bag is made from a polyolefin film. It contains materials that have been tested to demonstrate the suitability of the solution bag for storing pharmaceutical solutions. The solution contact layer is a polyolefin. The solution bag is nontoxic and biologically inert. The solution bag is a closed system and is not dependent upon entry of external air during administration. The solution bag is covered with a clear overwrap to provide protection from the physical environment. The content of the solution bag is considered sterile. This product has a sterile fluid path only. The clear overwrap is not considered a sterile barrier."
    },
    {
      "NDCCode": "14537-824-10",
      "PackageDescription": "6 POUCH in 1 CARTON (14537-824-10)  / 6 BAG in 1 POUCH / 100 mL in 1 BAG",
      "NDC11Code": "14537-0824-10",
      "ProductNDC": "14537-824",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Additive Formula 3",
      "NonProprietaryName": "Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20020529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN001214",
      "LabelerName": "Terumo BCT, Ltd",
      "SubstanceName": "ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".03; .042; 1.1; .41; .28; .59",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).].",
      "Description": "ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration."
    },
    {
      "NDCCode": "14537-826-20",
      "PackageDescription": "30 BAG in 1 CARTON (14537-826-20)  / 200 mL in 1 BAG",
      "NDC11Code": "14537-0826-20",
      "ProductNDC": "14537-826",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Additive Formula 3",
      "NonProprietaryName": "Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20020529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN001214",
      "LabelerName": "Terumo BCT, Ltd",
      "SubstanceName": "ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".03; .042; 1.1; .41; .28; .59",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).].",
      "Description": "ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration."
    },
    {
      "NDCCode": "14537-828-35",
      "PackageDescription": "24 BAG in 1 CARTON (14537-828-35)  / 350 mL in 1 BAG",
      "NDC11Code": "14537-0828-35",
      "ProductNDC": "14537-828",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Additive Formula 3",
      "NonProprietaryName": "Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20020529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN001214",
      "LabelerName": "Terumo BCT, Ltd",
      "SubstanceName": "ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".03; .042; 1.1; .41; .28; .59",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).].",
      "Description": "ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration."
    },
    {
      "NDCCode": "14537-832-03",
      "PackageDescription": "6 POUCH in 1 CASE (14537-832-03)  / 6 BAG in 1 POUCH (14537-832-01)  / 100 mL in 1 BAG (14537-832-00) ",
      "NDC11Code": "14537-0832-03",
      "ProductNDC": "14537-832",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Additive Formula 3",
      "NonProprietaryName": "Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20020529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN001214",
      "LabelerName": "Terumo BCT, Ltd",
      "SubstanceName": "ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".03; .042; 1.1; .41; .28; .59",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20020529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).].",
      "Description": "ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. Additive Solution Formula 3 (AS-3) is a clear solution that is steam-sterilized and non-pyrogenic. It does not contain bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration."
    },
    {
      "NDCCode": "14537-833-03",
      "PackageDescription": "30 BAG in 1 CASE (14537-833-03)  / 200 mL in 1 BAG (14537-833-00) ",
      "NDC11Code": "14537-0833-03",
      "ProductNDC": "14537-833",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Additive Formula 3",
      "NonProprietaryName": "Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20020529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN001214",
      "LabelerName": "Terumo BCT, Ltd",
      "SubstanceName": "ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".03; .042; 1.1; .41; .28; .59",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20020529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).].",
      "Description": "ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. Additive Solution Formula 3 (AS-3) is a clear solution that is steam-sterilized and non-pyrogenic. It does not contain bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration."
    },
    {
      "NDCCode": "14537-834-03",
      "PackageDescription": "24 BAG in 1 CASE (14537-834-03)  / 350 mL in 1 BAG (14537-834-00) ",
      "NDC11Code": "14537-0834-03",
      "ProductNDC": "14537-834",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Additive Formula 3",
      "NonProprietaryName": "Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20020529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN001214",
      "LabelerName": "Terumo BCT, Ltd",
      "SubstanceName": "ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": ".03; .042; 1.1; .41; .28; .59",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020529",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).].",
      "Description": "ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. Additive Solution Formula 3 (AS-3) is a clear solution that is steam-sterilized and non-pyrogenic. It does not contain bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration."
    },
    {
      "NDCCode": "14537-881-25",
      "PackageDescription": "30 BAG in 1 CARTON (14537-881-25)  / 250 mL in 1 BAG",
      "NDC11Code": "14537-0881-25",
      "ProductNDC": "14537-881",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Citrate 4% W/v Anticoagulant",
      "NonProprietaryName": "Trisodium Citrate Dihydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180626",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "BA125608",
      "LabelerName": "Terumo BCT, Ltd",
      "SubstanceName": "TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": "4",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-01-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180626",
      "SamplePackage": "N",
      "IndicationAndUsage": "SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [See Dosage and Administration (2).].",
      "Description": "SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP contains: Sodium Citrate (dihydrate) 4.0 g; and 100mL Water for Injection (pH adjusted with citric acid). The PVC bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary."
    },
    {
      "NDCCode": "14537-883-03",
      "PackageDescription": "30 BAG in 1 CARTON (14537-883-03)  / 250 mL in 1 BAG (14537-883-00) ",
      "NDC11Code": "14537-0883-03",
      "ProductNDC": "14537-883",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Citrate W/v Anticoagulant",
      "NonProprietaryName": "Trisodium Citrate Dihydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180626",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "BA125608",
      "LabelerName": "Terumo BCT, Ltd",
      "SubstanceName": "TRISODIUM CITRATE DIHYDRATE",
      "StrengthNumber": "4",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180626",
      "SamplePackage": "N",
      "IndicationAndUsage": "SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [See Dosage and Administration (2).].",
      "Description": "SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. Sterilized with steam. The formulas of the active ingredients are provided in Table 1. Each 100 mL of SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP contains: Sodium Citrate (dihydrate) 4.0 g; and Water for Injection to 100 mL (pH adjusted with citric acid). Approximate millimoles of sodium citrate: 13.8. The polyolefin bag is not made with natural rubber latex. The bag contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary."
    },
    {
      "NDCCode": "14537-966-10",
      "PackageDescription": "6 POUCH in 1 CASE (14537-966-10)  / 6 BAG in 1 POUCH / 100 mL in 1 BAG",
      "NDC11Code": "14537-0966-10",
      "ProductNDC": "14537-966",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "As",
      "ProprietaryNameSuffix": "3",
      "NonProprietaryName": "Dextrose Monohydrate, Sodium Citrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate And Adenine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20020529",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN001214",
      "LabelerName": "Terumo BCT Ltd",
      "SubstanceName": "ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM CITRATE, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
      "StrengthNumber": ".03; .042; 1.1; .41; .588; .276",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020529",
      "SamplePackage": "N",
      "Description": "Intended for use only with Trima and Trima Accel automated red blood cell apheresis devices and Atreus Whole Blood Processing System. See Operator's Manuals for additional information and complete usage instructions. Sterile. Non-pyrogenic. Do not use unless the solution is clear and the container is intact. Rx only. Single use container."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"14537-817-75","ProprietaryName":"Acd","NonProprietaryName":"Citric Acid Monohydrate, Dextrose Monohydrate, And Trisodium Citrate Dihydrate"},{"NDCCode":"14537-967-75","ProprietaryName":"Acd","NonProprietaryName":"Dextrose Monohydrate, Sodium Citrate, And Citric Acid Monohydrate"},{"NDCCode":"16714-817-01","ProprietaryName":"Oseltamivir Phosphate","NonProprietaryName":"Oseltamivir Phosphate"},{"NDCCode":"50268-817-15","ProprietaryName":"Venlafaxine Hydrochloride","NonProprietaryName":"Venlafaxine Hydrochloride"},{"NDCCode":"55700-817-30","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"55700-817-60","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"55700-817-90","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"14537-089-40","NonProprietaryName":"Levetiracetam"},{"NDCCode":"14537-091-40","NonProprietaryName":"Levetiracetam"},{"NDCCode":"14537-092-40","NonProprietaryName":"Levetiracetam"},{"NDCCode":"14537-093-50","NonProprietaryName":"Potassium Chloride"},{"NDCCode":"14537-094-40","NonProprietaryName":"Potassium Chloride"},{"NDCCode":"14537-095-50","NonProprietaryName":"Potassium Chloride"},{"NDCCode":"14537-096-40","NonProprietaryName":"Potassium Chloride"},{"NDCCode":"14537-097-40","NonProprietaryName":"Potassium Chloride"},{"NDCCode":"14537-102-20","NonProprietaryName":"Tirofiban Hydrochloride"},{"NDCCode":"14537-115-08","NonProprietaryName":"Tranexamic Acid"},{"NDCCode":"14537-115-30","NonProprietaryName":"Tranexamic Acid"},{"NDCCode":"14537-408-50","ProprietaryName":"Isoplate","NonProprietaryName":"Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate, Monobasic"},{"NDCCode":"14537-815-50","ProprietaryName":"Acd","NonProprietaryName":"Citric Acid Monohydrate, Dextrose Monohydrate, And Trisodium Citrate Dihydrate"},{"NDCCode":"14537-820-03","ProprietaryName":"Anticoagulant Citrate Dextrose (acd-a)","NonProprietaryName":"Dextrose Monohydrate, Sodium Citrate, Unspecified Form, And Citric Acid Monohydrate"},{"NDCCode":"14537-824-10","ProprietaryName":"Additive Formula 3","NonProprietaryName":"Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine"},{"NDCCode":"14537-826-20","ProprietaryName":"Additive Formula 3","NonProprietaryName":"Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine"},{"NDCCode":"14537-828-35","ProprietaryName":"Additive Formula 3","NonProprietaryName":"Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine"},{"NDCCode":"14537-832-03","ProprietaryName":"Additive Formula 3","NonProprietaryName":"Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine"},{"NDCCode":"14537-833-03","ProprietaryName":"Additive Formula 3","NonProprietaryName":"Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine"},{"NDCCode":"14537-834-03","ProprietaryName":"Additive Formula 3","NonProprietaryName":"Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine"},{"NDCCode":"14537-881-25","ProprietaryName":"Sodium Citrate 4% W/v Anticoagulant","NonProprietaryName":"Trisodium Citrate Dihydrate"},{"NDCCode":"14537-883-03","ProprietaryName":"Sodium Citrate W/v Anticoagulant","NonProprietaryName":"Trisodium Citrate Dihydrate"},{"NDCCode":"14537-966-10","ProprietaryName":"As","NonProprietaryName":"Dextrose Monohydrate, Sodium Citrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate And Adenine"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>14537-817-75</NDCCode>
    <PackageDescription>12 BAG in 1 CARTON (14537-817-75)  / 750 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0817-75</NDC11Code>
    <ProductNDC>14537-817</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acd</ProprietaryName>
    <ProprietaryNameSuffix>A</ProprietaryNameSuffix>
    <NonProprietaryName>Citric Acid Monohydrate, Dextrose Monohydrate, And Trisodium Citrate Dihydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020225</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>BA010228</ApplicationNumber>
    <LabelerName>Terumo BCT, Ltd.</LabelerName>
    <SubstanceName>CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
    <StrengthNumber>.8; 2.45; 2.2</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020225</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant for blood collection for use only with apheresis devices. [See Dosage and Administration (2).].</IndicationAndUsage>
    <Description>ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A contains: (%w/v) Citric Acid, Monohydrate 0.8 g; Dextrose Monohydrate 2.45 g; Sodium Citrate Dihydrate 2.2 g; and Water for Injection. The polyolefin bag is not made with natural rubber latex or PVC. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The solution contact layer is an elasticized polyolefin. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-967-75</NDCCode>
    <PackageDescription>12 BAG in 1 CASE (14537-967-75)  / 750 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0967-75</NDC11Code>
    <ProductNDC>14537-967</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acd</ProprietaryName>
    <ProprietaryNameSuffix>A</ProprietaryNameSuffix>
    <NonProprietaryName>Dextrose Monohydrate, Sodium Citrate, And Citric Acid Monohydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020225</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>BA010228</ApplicationNumber>
    <LabelerName>Terumo BCT Ltd</LabelerName>
    <SubstanceName>CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>.8; 2.45; 2.2</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020225</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Sterile. Non-pyrogenic. Do not use unless the solution is clear and the container is intact. Rx Only. Single use container. For use only with apheresis devices. See apheresis device operator's manual for complete instructions.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-817-01</NDCCode>
    <PackageDescription>10 CAPSULE in 1 CARTON (16714-817-01) </PackageDescription>
    <NDC11Code>16714-0817-01</NDC11Code>
    <ProductNDC>16714-817</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
    <NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180903</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209438</ApplicationNumber>
    <LabelerName>NorthStar RxLLC</LabelerName>
    <SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180903</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oseltamivir phosphate  is an influenza neuraminidase inhibitor (NAI) indicated for:  Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1)  Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use:   Not a substitute for annual influenza vaccination. (1.3)  Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3)  Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).</IndicationAndUsage>
    <Description>Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as:  Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&amp;C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch.  Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:.</Description>
  </NDC>
  <NDC>
    <NDCCode>50268-817-15</NDCCode>
    <PackageDescription>50 BLISTER PACK in 1 BOX (50268-817-15)  / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-817-11) </PackageDescription>
    <NDC11Code>50268-0817-15</NDC11Code>
    <ProductNDC>50268-817</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210427</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203332</ApplicationNumber>
    <LabelerName>AvPAK</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-05-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Venlafaxine Hydrochloride Extended-release Capsules, USP for once-a-day oral administration that contains venlafaxine hydrochloride a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethylcellulose, hypromellose and sugar spheres. The empty hard gelatin capsule shells contain gelatin and titanium dioxide. The 37.5 mg capsules also contain iron oxide black. The 75 mg capsules also contain FD&amp;C red No. 3 and FD&amp;C yellow No. 6. The 150 mg capsules also contain iron oxide red and iron oxide yellow. The 37.5 mg, 75 mg and 150 mg capsules are imprinted with black and grey ink which contains iron oxide black, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Grey ink also contains titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55700-817-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (55700-817-30) </PackageDescription>
    <NDC11Code>55700-0817-30</NDC11Code>
    <ProductNDC>55700-817</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208677</ApplicationNumber>
    <LabelerName>Quality Care Products, LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for.  Management of neuropathic pain associated with diabetic peripheral neuropathy.  Management of postherpetic neuralgia.  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older.  Management of fibromyalgia.  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&amp;C Blue 1, FD&amp;C Red 40 and FD&amp;C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55700-817-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (55700-817-60) </PackageDescription>
    <NDC11Code>55700-0817-60</NDC11Code>
    <ProductNDC>55700-817</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208677</ApplicationNumber>
    <LabelerName>Quality Care Products, LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for.  Management of neuropathic pain associated with diabetic peripheral neuropathy.  Management of postherpetic neuralgia.  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older.  Management of fibromyalgia.  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&amp;C Blue 1, FD&amp;C Red 40 and FD&amp;C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55700-817-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (55700-817-90) </PackageDescription>
    <NDC11Code>55700-0817-90</NDC11Code>
    <ProductNDC>55700-817</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208677</ApplicationNumber>
    <LabelerName>Quality Care Products, LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for.  Management of neuropathic pain associated with diabetic peripheral neuropathy.  Management of postherpetic neuralgia.  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older.  Management of fibromyalgia.  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&amp;C Blue 1, FD&amp;C Red 40 and FD&amp;C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-089-40</NDCCode>
    <PackageDescription>40 BAG in 1 BOX (14537-089-40)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0089-40</NDC11Code>
    <ProductNDC>14537-089</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <StartMarketingDate>20200626</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Terumo BCT Ltd.</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-JAN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14537-091-40</NDCCode>
    <PackageDescription>40 BAG in 1 BOX (14537-091-40)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0091-40</NDC11Code>
    <ProductNDC>14537-091</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <StartMarketingDate>20200626</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Terumo BCT Ltd.</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-JAN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14537-092-40</NDCCode>
    <PackageDescription>40 BAG in 1 BOX (14537-092-40)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0092-40</NDC11Code>
    <ProductNDC>14537-092</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <StartMarketingDate>20200626</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Terumo BCT Ltd.</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-JAN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14537-093-50</NDCCode>
    <PackageDescription>50 BAG in 1 BOX (14537-093-50)  / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0093-50</NDC11Code>
    <ProductNDC>14537-093</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20210326</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Terumo BCT Ltd.</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>meq/50mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-JAN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14537-094-40</NDCCode>
    <PackageDescription>40 BAG in 1 BOX (14537-094-40)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0094-40</NDC11Code>
    <ProductNDC>14537-094</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20210326</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Terumo BCT Ltd.</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>meq/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-JAN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14537-095-50</NDCCode>
    <PackageDescription>50 BAG in 1 BOX (14537-095-50)  / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0095-50</NDC11Code>
    <ProductNDC>14537-095</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20210326</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Terumo BCT Ltd.</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>meq/50mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-JAN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14537-096-40</NDCCode>
    <PackageDescription>40 BAG in 1 BOX (14537-096-40)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0096-40</NDC11Code>
    <ProductNDC>14537-096</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20210326</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Terumo BCT Ltd.</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>meq/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-JAN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14537-097-40</NDCCode>
    <PackageDescription>40 BAG in 1 BOX (14537-097-40)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0097-40</NDC11Code>
    <ProductNDC>14537-097</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20210326</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Terumo BCT Ltd.</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>meq/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-JAN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14537-102-20</NDCCode>
    <PackageDescription>20 BAG in 1 BOX (14537-102-20)  / 250 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0102-20</NDC11Code>
    <ProductNDC>14537-102</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Tirofiban Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <StartMarketingDate>20230608</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>TERUMO BCT LTD</LabelerName>
    <SubstanceName>TIROFIBAN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/250mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>08-JUN-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14537-115-08</NDCCode>
    <PackageDescription>30 BAG in 1 BOX (14537-115-08)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0115-08</NDC11Code>
    <ProductNDC>14537-115</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Tranexamic Acid</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <StartMarketingDate>20230314</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>TERUMO BCT LTD</LabelerName>
    <SubstanceName>TRANEXAMIC ACID</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>14-MAR-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14537-115-30</NDCCode>
    <PackageDescription>30 BAG in 1 BOX (14537-115-30)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0115-30</NDC11Code>
    <ProductNDC>14537-115</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Tranexamic Acid</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <StartMarketingDate>20230314</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>TERUMO BCT LTD</LabelerName>
    <SubstanceName>TRANEXAMIC ACID</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-NOV-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14537-408-50</NDCCode>
    <PackageDescription>18 CONTAINER in 1 CASE (14537-408-50)  / 500 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>14537-0408-50</NDC11Code>
    <ProductNDC>14537-408</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isoplate</ProprietaryName>
    <NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate, Monobasic</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20130305</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN090067</ApplicationNumber>
    <LabelerName>Terumo BCT Ltd.</LabelerName>
    <SubstanceName>MAGNESIUM CHLORIDE; MONOBASIC POTASSIUM PHOSPHATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>.03; .00082; .037; .37; .53; .5; .008</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], 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], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130305</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic solution to replace a portion of the plasma to store Platelets Pheresis Platelet Additive Solution (PAS) Added Leukocytes Reduced products collected using a hyperconcentrated collection on Terumo BCT's Trima Accel system [See Dosage and Administration (2).]. Platelets Pheresis PAS Added Leukocytes Reduced products are stored in a mix of 65% ISOPLATE SOLUTION and 35% plasma. Platelets in the solution can be stored at a concentration range of 0.7 to 2.1 × 106/µL for up to 5 days at 20-24 °C with continuous agitation in the Terumo BCT ELP bag [citrated polyvinyl chloride (PVC)] [See Clinical Studies (14).].</IndicationAndUsage>
    <Description>ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic solution designed to replace a proportion of the plasma used in the storage of Platelet Pheresis, Leukocytes Reduced PAS products collected using a hyperconcentrated collection on Terumo BCT's Trima Accel system. The solution is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ISOPLATE SOLUTION contains: Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g; Sodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 g; Magnesium Chloride Hexahydrate USP 0.03 g; Dibasic Sodium Phosphate Dihydrate USP 0.008 g; Monobasic Potassium Phosphate NF 0.00082 g; in Water for Injection USP. pH may be adjusted with glacial Acetic Acid USP or Sodium Hydroxide NF pH: 7.4 (7.0-7.8). Concentration of Electrolytes (mEq/liter): Sodium 141; Potassium 5; Magnesium 3; Chloride 98; Phosphate (HPO=4 ) 1 (0.5 mmole P/liter); Acetate (CH3COO–) 27; Gluconate (HOCH2(CHOH)4COO–) 23. The polyolefin bag is not made with natural rubber latex or PVC. Di(2-ethylhexyl)phthalate (DEHP) is present only in sterile dock tube. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The solution contact layer is an elasticized polyolefin. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-815-50</NDCCode>
    <PackageDescription>18 BAG in 1 CARTON (14537-815-50)  / 500 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0815-50</NDC11Code>
    <ProductNDC>14537-815</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acd</ProprietaryName>
    <ProprietaryNameSuffix>A</ProprietaryNameSuffix>
    <NonProprietaryName>Citric Acid Monohydrate, Dextrose Monohydrate, And Trisodium Citrate Dihydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020225</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>BA010228</ApplicationNumber>
    <LabelerName>Terumo BCT, Ltd.</LabelerName>
    <SubstanceName>CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
    <StrengthNumber>.8; 2.45; 2.2</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020225</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant for blood collection for use only with apheresis devices. [See Dosage and Administration (2).].</IndicationAndUsage>
    <Description>ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A contains: (%w/v) Citric Acid, Monohydrate 0.8 g; Dextrose Monohydrate 2.45 g; Sodium Citrate Dihydrate 2.2 g; and Water for Injection. The polyolefin bag is not made with natural rubber latex or PVC. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The solution contact layer is an elasticized polyolefin. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-820-03</NDCCode>
    <PackageDescription>50 POUCH in 1 CASE (14537-820-03)  / 1 BAG in 1 POUCH (14537-820-01)  / 50 mL in 1 BAG (14537-820-00) </PackageDescription>
    <NDC11Code>14537-0820-03</NDC11Code>
    <ProductNDC>14537-820</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Anticoagulant Citrate Dextrose (acd-a)</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate, Sodium Citrate, Unspecified Form, And Citric Acid Monohydrate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230718</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>BA110057</ApplicationNumber>
    <LabelerName>Terumo BCT, Ltd</LabelerName>
    <SubstanceName>CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>.08; .245; .22</StrengthNumber>
    <StrengthUnit>g/10mL; g/10mL; g/10mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230718</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. [See Dosage and Administration (2).].</IndicationAndUsage>
    <Description>ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is designed to be added to blood products collected for extracorporeal processing, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal processing set. The content of the solution bag is considered sterile. This product has a sterile fluid path only. The clear overwrap is not considered a sterile barrier. The solution is non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A contains: (%w/v) Citric Acid, Monohydrate 0.8 g; Dextrose Monohydrate 2.45 g; Sodium Citrate Dihydrate 2.2 g; and Water for Injection. The solution bag is not made with natural rubber latex or PVC. The solution bag is made from a polyolefin film. It contains materials that have been tested to demonstrate the suitability of the solution bag for storing pharmaceutical solutions. The solution contact layer is a polyolefin. The solution bag is nontoxic and biologically inert. The solution bag is a closed system and is not dependent upon entry of external air during administration. The solution bag is covered with a clear overwrap to provide protection from the physical environment. The content of the solution bag is considered sterile. This product has a sterile fluid path only. The clear overwrap is not considered a sterile barrier.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-824-10</NDCCode>
    <PackageDescription>6 POUCH in 1 CARTON (14537-824-10)  / 6 BAG in 1 POUCH / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0824-10</NDC11Code>
    <ProductNDC>14537-824</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Additive Formula 3</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020529</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN001214</ApplicationNumber>
    <LabelerName>Terumo BCT, Ltd</LabelerName>
    <SubstanceName>ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
    <StrengthNumber>.03; .042; 1.1; .41; .28; .59</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).].</IndicationAndUsage>
    <Description>ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-826-20</NDCCode>
    <PackageDescription>30 BAG in 1 CARTON (14537-826-20)  / 200 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0826-20</NDC11Code>
    <ProductNDC>14537-826</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Additive Formula 3</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020529</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN001214</ApplicationNumber>
    <LabelerName>Terumo BCT, Ltd</LabelerName>
    <SubstanceName>ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
    <StrengthNumber>.03; .042; 1.1; .41; .28; .59</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).].</IndicationAndUsage>
    <Description>ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-828-35</NDCCode>
    <PackageDescription>24 BAG in 1 CARTON (14537-828-35)  / 350 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0828-35</NDC11Code>
    <ProductNDC>14537-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Additive Formula 3</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020529</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN001214</ApplicationNumber>
    <LabelerName>Terumo BCT, Ltd</LabelerName>
    <SubstanceName>ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
    <StrengthNumber>.03; .042; 1.1; .41; .28; .59</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).].</IndicationAndUsage>
    <Description>ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-832-03</NDCCode>
    <PackageDescription>6 POUCH in 1 CASE (14537-832-03)  / 6 BAG in 1 POUCH (14537-832-01)  / 100 mL in 1 BAG (14537-832-00) </PackageDescription>
    <NDC11Code>14537-0832-03</NDC11Code>
    <ProductNDC>14537-832</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Additive Formula 3</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020529</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN001214</ApplicationNumber>
    <LabelerName>Terumo BCT, Ltd</LabelerName>
    <SubstanceName>ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
    <StrengthNumber>.03; .042; 1.1; .41; .28; .59</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).].</IndicationAndUsage>
    <Description>ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. Additive Solution Formula 3 (AS-3) is a clear solution that is steam-sterilized and non-pyrogenic. It does not contain bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-833-03</NDCCode>
    <PackageDescription>30 BAG in 1 CASE (14537-833-03)  / 200 mL in 1 BAG (14537-833-00) </PackageDescription>
    <NDC11Code>14537-0833-03</NDC11Code>
    <ProductNDC>14537-833</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Additive Formula 3</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020529</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN001214</ApplicationNumber>
    <LabelerName>Terumo BCT, Ltd</LabelerName>
    <SubstanceName>ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
    <StrengthNumber>.03; .042; 1.1; .41; .28; .59</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).].</IndicationAndUsage>
    <Description>ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. Additive Solution Formula 3 (AS-3) is a clear solution that is steam-sterilized and non-pyrogenic. It does not contain bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-834-03</NDCCode>
    <PackageDescription>24 BAG in 1 CASE (14537-834-03)  / 350 mL in 1 BAG (14537-834-00) </PackageDescription>
    <NDC11Code>14537-0834-03</NDC11Code>
    <ProductNDC>14537-834</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Additive Formula 3</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020529</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN001214</ApplicationNumber>
    <LabelerName>Terumo BCT, Ltd</LabelerName>
    <SubstanceName>ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
    <StrengthNumber>.03; .042; 1.1; .41; .28; .59</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).].</IndicationAndUsage>
    <Description>ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. Additive Solution Formula 3 (AS-3) is a clear solution that is steam-sterilized and non-pyrogenic. It does not contain bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-881-25</NDCCode>
    <PackageDescription>30 BAG in 1 CARTON (14537-881-25)  / 250 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0881-25</NDC11Code>
    <ProductNDC>14537-881</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Citrate 4% W/v Anticoagulant</ProprietaryName>
    <NonProprietaryName>Trisodium Citrate Dihydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180626</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>BA125608</ApplicationNumber>
    <LabelerName>Terumo BCT, Ltd</LabelerName>
    <SubstanceName>TRISODIUM CITRATE DIHYDRATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180626</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [See Dosage and Administration (2).].</IndicationAndUsage>
    <Description>SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP contains: Sodium Citrate (dihydrate) 4.0 g; and 100mL Water for Injection (pH adjusted with citric acid). The PVC bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-883-03</NDCCode>
    <PackageDescription>30 BAG in 1 CARTON (14537-883-03)  / 250 mL in 1 BAG (14537-883-00) </PackageDescription>
    <NDC11Code>14537-0883-03</NDC11Code>
    <ProductNDC>14537-883</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Citrate W/v Anticoagulant</ProprietaryName>
    <NonProprietaryName>Trisodium Citrate Dihydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180626</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>BA125608</ApplicationNumber>
    <LabelerName>Terumo BCT, Ltd</LabelerName>
    <SubstanceName>TRISODIUM CITRATE DIHYDRATE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180626</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [See Dosage and Administration (2).].</IndicationAndUsage>
    <Description>SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. Sterilized with steam. The formulas of the active ingredients are provided in Table 1. Each 100 mL of SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP contains: Sodium Citrate (dihydrate) 4.0 g; and Water for Injection to 100 mL (pH adjusted with citric acid). Approximate millimoles of sodium citrate: 13.8. The polyolefin bag is not made with natural rubber latex. The bag contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-966-10</NDCCode>
    <PackageDescription>6 POUCH in 1 CASE (14537-966-10)  / 6 BAG in 1 POUCH / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0966-10</NDC11Code>
    <ProductNDC>14537-966</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>As</ProprietaryName>
    <ProprietaryNameSuffix>3</ProprietaryNameSuffix>
    <NonProprietaryName>Dextrose Monohydrate, Sodium Citrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate And Adenine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020529</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN001214</ApplicationNumber>
    <LabelerName>Terumo BCT Ltd</LabelerName>
    <SubstanceName>ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM CITRATE, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE</SubstanceName>
    <StrengthNumber>.03; .042; 1.1; .41; .588; .276</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Intended for use only with Trima and Trima Accel automated red blood cell apheresis devices and Atreus Whole Blood Processing System. See Operator's Manuals for additional information and complete usage instructions. Sterile. Non-pyrogenic. Do not use unless the solution is clear and the container is intact. Rx only. Single use container.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>14537-817-75</NDCCode><ProprietaryName>Acd</ProprietaryName><NonProprietaryName>Citric Acid Monohydrate, Dextrose Monohydrate, And Trisodium Citrate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>14537-967-75</NDCCode><ProprietaryName>Acd</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Citrate, And Citric Acid Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>16714-817-01</NDCCode><ProprietaryName>Oseltamivir Phosphate</ProprietaryName><NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName></NDC><NDC><NDCCode>50268-817-15</NDCCode><ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName><NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55700-817-30</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>55700-817-60</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>55700-817-90</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>14537-089-40</NDCCode><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>14537-091-40</NDCCode><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>14537-092-40</NDCCode><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>14537-093-50</NDCCode><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>14537-094-40</NDCCode><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>14537-095-50</NDCCode><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>14537-096-40</NDCCode><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>14537-097-40</NDCCode><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>14537-102-20</NDCCode><NonProprietaryName>Tirofiban Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>14537-115-08</NDCCode><NonProprietaryName>Tranexamic Acid</NonProprietaryName></NDC><NDC><NDCCode>14537-115-30</NDCCode><NonProprietaryName>Tranexamic Acid</NonProprietaryName></NDC><NDC><NDCCode>14537-408-50</NDCCode><ProprietaryName>Isoplate</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate, Monobasic</NonProprietaryName></NDC><NDC><NDCCode>14537-815-50</NDCCode><ProprietaryName>Acd</ProprietaryName><NonProprietaryName>Citric Acid Monohydrate, Dextrose Monohydrate, And Trisodium Citrate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>14537-820-03</NDCCode><ProprietaryName>Anticoagulant Citrate Dextrose (acd-a)</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Citrate, Unspecified Form, And Citric Acid Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>14537-824-10</NDCCode><ProprietaryName>Additive Formula 3</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine</NonProprietaryName></NDC><NDC><NDCCode>14537-826-20</NDCCode><ProprietaryName>Additive Formula 3</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine</NonProprietaryName></NDC><NDC><NDCCode>14537-828-35</NDCCode><ProprietaryName>Additive Formula 3</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine</NonProprietaryName></NDC><NDC><NDCCode>14537-832-03</NDCCode><ProprietaryName>Additive Formula 3</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine</NonProprietaryName></NDC><NDC><NDCCode>14537-833-03</NDCCode><ProprietaryName>Additive Formula 3</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine</NonProprietaryName></NDC><NDC><NDCCode>14537-834-03</NDCCode><ProprietaryName>Additive Formula 3</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine</NonProprietaryName></NDC><NDC><NDCCode>14537-881-25</NDCCode><ProprietaryName>Sodium Citrate 4% W/v Anticoagulant</ProprietaryName><NonProprietaryName>Trisodium Citrate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>14537-883-03</NDCCode><ProprietaryName>Sodium Citrate W/v Anticoagulant</ProprietaryName><NonProprietaryName>Trisodium Citrate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>14537-966-10</NDCCode><ProprietaryName>As</ProprietaryName><NonProprietaryName>Dextrose Monohydrate, Sodium Citrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate And Adenine</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
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      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
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}
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