{
"NDC": [
{
"NDCCode": "14445-146-36",
"PackageDescription": "1 BOTTLE in 1 CARTON (14445-146-36) / 36 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "14445-0146-36",
"ProductNDC": "14445-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lofexidine",
"NonProprietaryName": "Lofexidine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218613",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "LOFEXIDINE HYDROCHLORIDE",
"StrengthNumber": ".18",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240821",
"SamplePackage": "N",
"IndicationAndUsage": "Lofexidine tablets are indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.",
"Description": "Lofexidine tablets contain lofexidine, a central alpha-2 adrenergic agonist, as the hydrochloride salt. Lofexidine hydrochloride is chemically designated as 2-[1-(2,6-dichlorophenoxy)ethyl]-4,5 dihydro-1H- imidazole monohydrochloride with a molecular formula of C11H12Cl2N2OHCl. Its molecular weight is 295.6 g/mole and its structural formula is. Lofexidine hydrochloride is a white to off-white crystalline powder freely soluble in water, methanol, and ethanol. It is slightly soluble in chloroform and practically insoluble in n-hexane and benzene. Lofexidine tablet is available as round, concave-shaped, peach-colored, film-coated tablets, debossed with “C” on one side and “71” on other side for oral administration. Each tablet contains 0.18 lofexidine, equivalent to 0.2 mg of lofexidine hydrochloride and the following inactive ingredients: 87 mg lactose monohydrate, 12.3 mg citric acid monohydrate, 5.7 mg microcrystalline cellulose, 1.1 mg povidone K-30, 0.70 mg sodium lauryl sulphate, 5.0 mg sodium starch glycolate, 2.0 mg calcium stearate and Opadry AMB II orange 88A530003 (contains polyvinyl alcohol, talc, titanium dioxide, Glyceryl mono and dicaprylocaprate, sodium lauryl sulfate, FD&C yellow #6/sunset yellow FCF aluminum lake and FD&C blue #2/indigo carmine aluminium lake)."
},
{
"NDCCode": "14445-146-96",
"PackageDescription": "1 BOTTLE in 1 CARTON (14445-146-96) / 96 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "14445-0146-96",
"ProductNDC": "14445-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lofexidine",
"NonProprietaryName": "Lofexidine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218613",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "LOFEXIDINE HYDROCHLORIDE",
"StrengthNumber": ".18",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240821",
"SamplePackage": "N",
"IndicationAndUsage": "Lofexidine tablets are indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.",
"Description": "Lofexidine tablets contain lofexidine, a central alpha-2 adrenergic agonist, as the hydrochloride salt. Lofexidine hydrochloride is chemically designated as 2-[1-(2,6-dichlorophenoxy)ethyl]-4,5 dihydro-1H- imidazole monohydrochloride with a molecular formula of C11H12Cl2N2OHCl. Its molecular weight is 295.6 g/mole and its structural formula is. Lofexidine hydrochloride is a white to off-white crystalline powder freely soluble in water, methanol, and ethanol. It is slightly soluble in chloroform and practically insoluble in n-hexane and benzene. Lofexidine tablet is available as round, concave-shaped, peach-colored, film-coated tablets, debossed with “C” on one side and “71” on other side for oral administration. Each tablet contains 0.18 lofexidine, equivalent to 0.2 mg of lofexidine hydrochloride and the following inactive ingredients: 87 mg lactose monohydrate, 12.3 mg citric acid monohydrate, 5.7 mg microcrystalline cellulose, 1.1 mg povidone K-30, 0.70 mg sodium lauryl sulphate, 5.0 mg sodium starch glycolate, 2.0 mg calcium stearate and Opadry AMB II orange 88A530003 (contains polyvinyl alcohol, talc, titanium dioxide, Glyceryl mono and dicaprylocaprate, sodium lauryl sulfate, FD&C yellow #6/sunset yellow FCF aluminum lake and FD&C blue #2/indigo carmine aluminium lake)."
},
{
"NDCCode": "63354-942-36",
"PackageDescription": "146 g in 1 CAN (63354-942-36)",
"NDC11Code": "63354-0942-36",
"ProductNDC": "63354-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Banana Boat",
"NonProprietaryName": "Avobenzone, Octocrylene, Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111229",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Energizer Personal Care LLC",
"SubstanceName": "AVOBENZONE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 10; 5",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-10-13"
},
{
"NDCCode": "65862-146-36",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (65862-146-36) / 9 TABLET in 1 BLISTER PACK",
"NDC11Code": "65862-0146-36",
"ProductNDC": "65862-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078327",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090817",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. , 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks. , 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. .",
"Description": "Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet, USP for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate."
},
{
"NDCCode": "65862-146-59",
"PackageDescription": "36 TABLET in 1 BOTTLE (65862-146-59) ",
"NDC11Code": "65862-0146-59",
"ProductNDC": "65862-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078327",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220622",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. , 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks. , 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. .",
"Description": "Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet, USP for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate."
},
{
"NDCCode": "72888-146-36",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (72888-146-36) / 20 mL in 1 VIAL, GLASS",
"NDC11Code": "72888-0146-36",
"ProductNDC": "72888-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "INJECTION",
"RouteName": "INTRATHECAL",
"StartMarketingDate": "20230222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217324",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "1000",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230222",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of baclofen injection via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. Baclofen injection is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only with the Medtronic SynchroMed® II Programmable Pump or other pumps labeled for intrathecal administration of baclofen injection [see Clinical Studies(14)] . Prior to implantation of a device for chronic intrathecal infusion of baclofen injection, patients must show a response to baclofen injection in a screening trial [see Dosage and Administration(2.2)] .",
"Description": "Baclofen injection is a muscle relaxant and antispastic. Baclofen's pharmacological class is a gamma-aminobutyric acid (GABA)ergic agonist. Baclofen's chemical name is 4-amino- 3-(4-chlorophenyl) butanoic acid, and its structural formula is. Baclofen. C 10H 12ClNO 2. Baclofen is a white to off-white powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and ethanol, practically insoluble in acetone and ether, soluble in 0.1N hydrochloric acid, 0.1N sodium hydroxide, and insoluble in chloroform. Baclofen injection is a sterile, pyrogen-free, isotonic solution free of antioxidants, preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. The drug is stable in solution at 37°C and compatible with CSF. Each mL of baclofen injection contains baclofen USP 500 mcg, 1,000 mcg or 2,000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.5 to 7.5."
},
{
"NDCCode": "0338-0077-02",
"PackageDescription": "36 BAG in 1 CARTON (0338-0077-02) / 250 mL in 1 BAG",
"NDC11Code": "00338-0077-02",
"ProductNDC": "0338-0077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose And Sodium Chloride",
"NonProprietaryName": "Dextrose And Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19701208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016689",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE",
"StrengthNumber": "5; 200",
"StrengthUnit": "g/100mL; mg/100mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19701208",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories.",
"Description": "Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single-dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Dextrose is derived from corn. The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-1130-03",
"PackageDescription": "500 mL in 1 BAG (0338-1130-03) ",
"NDC11Code": "00338-1130-03",
"ProductNDC": "0338-1130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Premasol - Sulfite-free (amino Acid)",
"NonProprietaryName": "Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-acetyl-tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20030619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075880",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE",
"StrengthNumber": "1.4; .82; .82; .78; .48; .48; .42; .34; .2; .24; 1.2; .68; .54; .5; .38; .36; .32; 25; .016",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030619",
"SamplePackage": "N",
"IndicationAndUsage": "PREMASOL 10% injection is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with PREMASOL 10% injection is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance (see DOSAGE AND ADMINISTRATION).",
"Description": "PREMASOL 10% injection is a sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids provided in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period (e.g., di-2-ethylhexyl phthalate, DEHP, at not more than 0.2 part per million); however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate (DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers. Each 100 mL contains."
},
{
"NDCCode": "0338-1130-04",
"PackageDescription": "1000 mL in 1 BAG (0338-1130-04) ",
"NDC11Code": "00338-1130-04",
"ProductNDC": "0338-1130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Premasol - Sulfite-free (amino Acid)",
"NonProprietaryName": "Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-acetyl-tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20030619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075880",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE",
"StrengthNumber": "1.4; .82; .82; .78; .48; .48; .42; .34; .2; .24; 1.2; .68; .54; .5; .38; .36; .32; 25; .016",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030619",
"SamplePackage": "N",
"IndicationAndUsage": "PREMASOL 10% injection is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with PREMASOL 10% injection is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance (see DOSAGE AND ADMINISTRATION).",
"Description": "PREMASOL 10% injection is a sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids provided in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period (e.g., di-2-ethylhexyl phthalate, DEHP, at not more than 0.2 part per million); however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate (DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers. Each 100 mL contains."
},
{
"NDCCode": "0338-1130-06",
"PackageDescription": "2000 mL in 1 BAG (0338-1130-06) ",
"NDC11Code": "00338-1130-06",
"ProductNDC": "0338-1130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Premasol - Sulfite-free (amino Acid)",
"NonProprietaryName": "Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-acetyl-tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20030619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075880",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE",
"StrengthNumber": "1.4; .82; .82; .78; .48; .48; .42; .34; .2; .24; 1.2; .68; .54; .5; .38; .36; .32; 25; .016",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030619",
"SamplePackage": "N",
"IndicationAndUsage": "PREMASOL 10% injection is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with PREMASOL 10% injection is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance (see DOSAGE AND ADMINISTRATION).",
"Description": "PREMASOL 10% injection is a sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids provided in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period (e.g., di-2-ethylhexyl phthalate, DEHP, at not more than 0.2 part per million); however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate (DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers. Each 100 mL contains."
},
{
"NDCCode": "0597-0035-10",
"PackageDescription": "2 VIAL, GLASS in 1 CARTON (0597-0035-10) / 7.5 mL in 1 VIAL, GLASS",
"NDC11Code": "00597-0035-10",
"ProductNDC": "0597-0035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spevigo",
"NonProprietaryName": "Spesolimab-sbzo",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220901",
"EndMarketingDate": "20271130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761244",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "SPESOLIMAB",
"StrengthNumber": "60",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220901",
"EndMarketingDatePackage": "20271130",
"SamplePackage": "N",
"IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
"Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
},
{
"NDCCode": "0597-0620-20",
"PackageDescription": "2 SYRINGE in 1 CARTON (0597-0620-20) / 150 INJECTION in 1 SYRINGE (0597-0620-10) ",
"NDC11Code": "00597-0620-20",
"ProductNDC": "0597-0620",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spevigo",
"NonProprietaryName": "Spesolimab-sbzo",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240318",
"EndMarketingDate": "20270831",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761244",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "SPESOLIMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240318",
"EndMarketingDatePackage": "20270831",
"SamplePackage": "N",
"IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
"Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
},
{
"NDCCode": "0597-7705-41",
"PackageDescription": "1 SYRINGE in 1 CARTON (0597-7705-41) / 300 INJECTION in 1 SYRINGE (0597-7705-38) ",
"NDC11Code": "00597-7705-41",
"ProductNDC": "0597-7705",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spevigo",
"NonProprietaryName": "Spesolimab-sbzo",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250528",
"EndMarketingDate": "20270430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761244",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "SPESOLIMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250528",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
"Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
},
{
"NDCCode": "0597-7705-72",
"PackageDescription": "2 SYRINGE in 1 CARTON (0597-7705-72) / 300 INJECTION in 1 SYRINGE (0597-7705-38) ",
"NDC11Code": "00597-7705-72",
"ProductNDC": "0597-7705",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spevigo",
"NonProprietaryName": "Spesolimab-sbzo",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250528",
"EndMarketingDate": "20270430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761244",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "SPESOLIMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250528",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
"Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
},
{
"NDCCode": "50222-360-72",
"PackageDescription": "2 VIAL, GLASS in 1 CARTON (50222-360-72) / 7.5 mL in 1 VIAL, GLASS",
"NDC11Code": "50222-0360-72",
"ProductNDC": "50222-360",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spevigo",
"NonProprietaryName": "Spesolimab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260309",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761244",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "SPESOLIMAB",
"StrengthNumber": "60",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260309",
"SamplePackage": "N",
"IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
"Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
},
{
"NDCCode": "50222-361-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (50222-361-02) / 1 mL in 1 SYRINGE, GLASS (50222-361-11) ",
"NDC11Code": "50222-0361-02",
"ProductNDC": "50222-361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spevigo",
"NonProprietaryName": "Spesolimab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260309",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761244",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "SPESOLIMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260309",
"SamplePackage": "N",
"IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
"Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
},
{
"NDCCode": "50222-362-01",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (50222-362-01) / 2 mL in 1 SYRINGE, GLASS (50222-362-12) ",
"NDC11Code": "50222-0362-01",
"ProductNDC": "50222-362",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spevigo",
"NonProprietaryName": "Spesolimab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260309",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761244",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "SPESOLIMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260309",
"SamplePackage": "N",
"IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
"Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
},
{
"NDCCode": "50222-362-02",
"PackageDescription": "2 SYRINGE, GLASS in 1 CARTON (50222-362-02) / 2 mL in 1 SYRINGE, GLASS (50222-362-12) ",
"NDC11Code": "50222-0362-02",
"ProductNDC": "50222-362",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spevigo",
"NonProprietaryName": "Spesolimab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260309",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761244",
"LabelerName": "LEO Pharma Inc.",
"SubstanceName": "SPESOLIMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260309",
"SamplePackage": "N",
"IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
"Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
},
{
"NDCCode": "59148-400-75",
"PackageDescription": "1 SYRINGE in 1 CARTON (59148-400-75) / 2 mL in 1 SYRINGE",
"NDC11Code": "59148-0400-75",
"ProductNDC": "59148-400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voyxact",
"NonProprietaryName": "Sibeprenlimab",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251125",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761434",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "SIBEPRENLIMAB",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251125",
"SamplePackage": "N",
"IndicationAndUsage": "VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.",
"Description": "VOYXACT contains sibeprenlimab-szsi, an A Proliferation Inducing Ligand (APRIL) blocker and humanized immunoglobulin G2 (IgG2) monoclonal antibody produced by Chinese Hamster Ovary (CHO) cells. The approximate molecular weight of sibeprenlimab-szsi is 146 kDa. VOYXACT (sibeprenlimab-szsi) injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe delivers 400 mg sibeprenlimab-szsi and the inactive ingredients: arginine (17.6 mg), glutamic acid (14.8 mg), histidine (4.34 mg), L-histidine hydrochloride monohydrate (4.62 mg), polysorbate 80 (0.40 mg), sorbitol (36.4 mg), and Water for Injection, USP. The pH is 6.2."
},
{
"NDCCode": "14445-001-01",
"PackageDescription": "10 kg in 1 DRUM (14445-001-01) ",
"NDC11Code": "14445-0001-01",
"ProductNDC": "14445-001",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080115",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-03-12",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-JAN-08"
},
{
"NDCCode": "14445-001-02",
"PackageDescription": "25 kg in 1 DRUM (14445-001-02) ",
"NDC11Code": "14445-0001-02",
"ProductNDC": "14445-001",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080115",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-03-12",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-JAN-08"
},
{
"NDCCode": "14445-001-03",
"PackageDescription": "50 kg in 1 DRUM (14445-001-03) ",
"NDC11Code": "14445-0001-03",
"ProductNDC": "14445-001",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080115",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-03-12",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-JAN-08"
},
{
"NDCCode": "14445-002-01",
"PackageDescription": "10 kg in 1 DRUM (14445-002-01) ",
"NDC11Code": "14445-0002-01",
"ProductNDC": "14445-002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Betaxolol Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "BETAXOLOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-07-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "05-DEC-13"
},
{
"NDCCode": "14445-002-02",
"PackageDescription": "25 kg in 1 DRUM (14445-002-02) ",
"NDC11Code": "14445-0002-02",
"ProductNDC": "14445-002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Betaxolol Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "BETAXOLOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-07-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "05-DEC-13"
},
{
"NDCCode": "14445-002-03",
"PackageDescription": "50 kg in 1 DRUM (14445-002-03) ",
"NDC11Code": "14445-0002-03",
"ProductNDC": "14445-002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Betaxolol Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "BETAXOLOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-07-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "05-DEC-13"
},
{
"NDCCode": "14445-002-04",
"PackageDescription": "5 kg in 1 DRUM (14445-002-04) ",
"NDC11Code": "14445-0002-04",
"ProductNDC": "14445-002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Betaxolol Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "BETAXOLOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-07-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "08-MAR-24"
},
{
"NDCCode": "14445-002-05",
"PackageDescription": "1 kg in 1 DRUM (14445-002-05) ",
"NDC11Code": "14445-0002-05",
"ProductNDC": "14445-002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Betaxolol Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "BETAXOLOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-07-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "08-MAR-24"
},
{
"NDCCode": "14445-002-06",
"PackageDescription": "2 kg in 1 DRUM (14445-002-06) ",
"NDC11Code": "14445-0002-06",
"ProductNDC": "14445-002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Betaxolol Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "BETAXOLOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-07-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "08-MAR-24"
},
{
"NDCCode": "14445-002-07",
"PackageDescription": "3 kg in 1 DRUM (14445-002-07) ",
"NDC11Code": "14445-0002-07",
"ProductNDC": "14445-002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Betaxolol Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "BETAXOLOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-07-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "08-MAR-24"
},
{
"NDCCode": "14445-002-08",
"PackageDescription": ".5 kg in 1 DRUM (14445-002-08) ",
"NDC11Code": "14445-0002-08",
"ProductNDC": "14445-002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Betaxolol Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "BETAXOLOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-07-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "08-MAR-24"
}
]
}
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<NDCList>
<NDC>
<NDCCode>14445-146-36</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (14445-146-36) / 36 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>14445-0146-36</NDC11Code>
<ProductNDC>14445-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lofexidine</ProprietaryName>
<NonProprietaryName>Lofexidine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240821</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218613</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>LOFEXIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lofexidine tablets are indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.</IndicationAndUsage>
<Description>Lofexidine tablets contain lofexidine, a central alpha-2 adrenergic agonist, as the hydrochloride salt. Lofexidine hydrochloride is chemically designated as 2-[1-(2,6-dichlorophenoxy)ethyl]-4,5 dihydro-1H- imidazole monohydrochloride with a molecular formula of C11H12Cl2N2OHCl. Its molecular weight is 295.6 g/mole and its structural formula is. Lofexidine hydrochloride is a white to off-white crystalline powder freely soluble in water, methanol, and ethanol. It is slightly soluble in chloroform and practically insoluble in n-hexane and benzene. Lofexidine tablet is available as round, concave-shaped, peach-colored, film-coated tablets, debossed with “C” on one side and “71” on other side for oral administration. Each tablet contains 0.18 lofexidine, equivalent to 0.2 mg of lofexidine hydrochloride and the following inactive ingredients: 87 mg lactose monohydrate, 12.3 mg citric acid monohydrate, 5.7 mg microcrystalline cellulose, 1.1 mg povidone K-30, 0.70 mg sodium lauryl sulphate, 5.0 mg sodium starch glycolate, 2.0 mg calcium stearate and Opadry AMB II orange 88A530003 (contains polyvinyl alcohol, talc, titanium dioxide, Glyceryl mono and dicaprylocaprate, sodium lauryl sulfate, FD&C yellow #6/sunset yellow FCF aluminum lake and FD&C blue #2/indigo carmine aluminium lake).</Description>
</NDC>
<NDC>
<NDCCode>14445-146-96</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (14445-146-96) / 96 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>14445-0146-96</NDC11Code>
<ProductNDC>14445-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lofexidine</ProprietaryName>
<NonProprietaryName>Lofexidine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240821</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218613</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>LOFEXIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lofexidine tablets are indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.</IndicationAndUsage>
<Description>Lofexidine tablets contain lofexidine, a central alpha-2 adrenergic agonist, as the hydrochloride salt. Lofexidine hydrochloride is chemically designated as 2-[1-(2,6-dichlorophenoxy)ethyl]-4,5 dihydro-1H- imidazole monohydrochloride with a molecular formula of C11H12Cl2N2OHCl. Its molecular weight is 295.6 g/mole and its structural formula is. Lofexidine hydrochloride is a white to off-white crystalline powder freely soluble in water, methanol, and ethanol. It is slightly soluble in chloroform and practically insoluble in n-hexane and benzene. Lofexidine tablet is available as round, concave-shaped, peach-colored, film-coated tablets, debossed with “C” on one side and “71” on other side for oral administration. Each tablet contains 0.18 lofexidine, equivalent to 0.2 mg of lofexidine hydrochloride and the following inactive ingredients: 87 mg lactose monohydrate, 12.3 mg citric acid monohydrate, 5.7 mg microcrystalline cellulose, 1.1 mg povidone K-30, 0.70 mg sodium lauryl sulphate, 5.0 mg sodium starch glycolate, 2.0 mg calcium stearate and Opadry AMB II orange 88A530003 (contains polyvinyl alcohol, talc, titanium dioxide, Glyceryl mono and dicaprylocaprate, sodium lauryl sulfate, FD&C yellow #6/sunset yellow FCF aluminum lake and FD&C blue #2/indigo carmine aluminium lake).</Description>
</NDC>
<NDC>
<NDCCode>63354-942-36</NDCCode>
<PackageDescription>146 g in 1 CAN (63354-942-36)</PackageDescription>
<NDC11Code>63354-0942-36</NDC11Code>
<ProductNDC>63354-942</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Banana Boat</ProprietaryName>
<NonProprietaryName>Avobenzone, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111229</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Energizer Personal Care LLC</LabelerName>
<SubstanceName>AVOBENZONE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3; 10; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>65862-146-36</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (65862-146-36) / 9 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65862-0146-36</NDC11Code>
<ProductNDC>65862-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078327</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. , 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks. , 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. .</IndicationAndUsage>
<Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet, USP for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate.</Description>
</NDC>
<NDC>
<NDCCode>65862-146-59</NDCCode>
<PackageDescription>36 TABLET in 1 BOTTLE (65862-146-59) </PackageDescription>
<NDC11Code>65862-0146-59</NDC11Code>
<ProductNDC>65862-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078327</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. , 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks. , 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. .</IndicationAndUsage>
<Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet, USP for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate.</Description>
</NDC>
<NDC>
<NDCCode>72888-146-36</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (72888-146-36) / 20 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>72888-0146-36</NDC11Code>
<ProductNDC>72888-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRATHECAL</RouteName>
<StartMarketingDate>20230222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217324</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of baclofen injection via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. Baclofen injection is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only with the Medtronic SynchroMed® II Programmable Pump or other pumps labeled for intrathecal administration of baclofen injection [see Clinical Studies(14)] . Prior to implantation of a device for chronic intrathecal infusion of baclofen injection, patients must show a response to baclofen injection in a screening trial [see Dosage and Administration(2.2)] .</IndicationAndUsage>
<Description>Baclofen injection is a muscle relaxant and antispastic. Baclofen's pharmacological class is a gamma-aminobutyric acid (GABA)ergic agonist. Baclofen's chemical name is 4-amino- 3-(4-chlorophenyl) butanoic acid, and its structural formula is. Baclofen. C 10H 12ClNO 2. Baclofen is a white to off-white powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and ethanol, practically insoluble in acetone and ether, soluble in 0.1N hydrochloric acid, 0.1N sodium hydroxide, and insoluble in chloroform. Baclofen injection is a sterile, pyrogen-free, isotonic solution free of antioxidants, preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. The drug is stable in solution at 37°C and compatible with CSF. Each mL of baclofen injection contains baclofen USP 500 mcg, 1,000 mcg or 2,000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.5 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>0338-0077-02</NDCCode>
<PackageDescription>36 BAG in 1 CARTON (0338-0077-02) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-0077-02</NDC11Code>
<ProductNDC>0338-0077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose And Sodium Chloride</ProprietaryName>
<NonProprietaryName>Dextrose And Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19701208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016689</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>5; 200</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19701208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories.</IndicationAndUsage>
<Description>Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single-dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Dextrose is derived from corn. The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-1130-03</NDCCode>
<PackageDescription>500 mL in 1 BAG (0338-1130-03) </PackageDescription>
<NDC11Code>00338-1130-03</NDC11Code>
<ProductNDC>0338-1130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Premasol - Sulfite-free (amino Acid)</ProprietaryName>
<NonProprietaryName>Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-acetyl-tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20030619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075880</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.4; .82; .82; .78; .48; .48; .42; .34; .2; .24; 1.2; .68; .54; .5; .38; .36; .32; 25; .016</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREMASOL 10% injection is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with PREMASOL 10% injection is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>PREMASOL 10% injection is a sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids provided in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period (e.g., di-2-ethylhexyl phthalate, DEHP, at not more than 0.2 part per million); however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate (DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers. Each 100 mL contains.</Description>
</NDC>
<NDC>
<NDCCode>0338-1130-04</NDCCode>
<PackageDescription>1000 mL in 1 BAG (0338-1130-04) </PackageDescription>
<NDC11Code>00338-1130-04</NDC11Code>
<ProductNDC>0338-1130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Premasol - Sulfite-free (amino Acid)</ProprietaryName>
<NonProprietaryName>Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-acetyl-tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20030619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075880</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.4; .82; .82; .78; .48; .48; .42; .34; .2; .24; 1.2; .68; .54; .5; .38; .36; .32; 25; .016</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREMASOL 10% injection is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with PREMASOL 10% injection is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>PREMASOL 10% injection is a sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids provided in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period (e.g., di-2-ethylhexyl phthalate, DEHP, at not more than 0.2 part per million); however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate (DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers. Each 100 mL contains.</Description>
</NDC>
<NDC>
<NDCCode>0338-1130-06</NDCCode>
<PackageDescription>2000 mL in 1 BAG (0338-1130-06) </PackageDescription>
<NDC11Code>00338-1130-06</NDC11Code>
<ProductNDC>0338-1130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Premasol - Sulfite-free (amino Acid)</ProprietaryName>
<NonProprietaryName>Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-acetyl-tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20030619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075880</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.4; .82; .82; .78; .48; .48; .42; .34; .2; .24; 1.2; .68; .54; .5; .38; .36; .32; 25; .016</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREMASOL 10% injection is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with PREMASOL 10% injection is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>PREMASOL 10% injection is a sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids provided in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period (e.g., di-2-ethylhexyl phthalate, DEHP, at not more than 0.2 part per million); however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate (DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers. Each 100 mL contains.</Description>
</NDC>
<NDC>
<NDCCode>0597-0035-10</NDCCode>
<PackageDescription>2 VIAL, GLASS in 1 CARTON (0597-0035-10) / 7.5 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00597-0035-10</NDC11Code>
<ProductNDC>0597-0035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spevigo</ProprietaryName>
<NonProprietaryName>Spesolimab-sbzo</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220901</StartMarketingDate>
<EndMarketingDate>20271130</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761244</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SPESOLIMAB</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220901</StartMarketingDatePackage>
<EndMarketingDatePackage>20271130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.</IndicationAndUsage>
<Description>Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8.</Description>
</NDC>
<NDC>
<NDCCode>0597-0620-20</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0597-0620-20) / 150 INJECTION in 1 SYRINGE (0597-0620-10) </PackageDescription>
<NDC11Code>00597-0620-20</NDC11Code>
<ProductNDC>0597-0620</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spevigo</ProprietaryName>
<NonProprietaryName>Spesolimab-sbzo</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240318</StartMarketingDate>
<EndMarketingDate>20270831</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761244</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SPESOLIMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240318</StartMarketingDatePackage>
<EndMarketingDatePackage>20270831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.</IndicationAndUsage>
<Description>Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8.</Description>
</NDC>
<NDC>
<NDCCode>0597-7705-41</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0597-7705-41) / 300 INJECTION in 1 SYRINGE (0597-7705-38) </PackageDescription>
<NDC11Code>00597-7705-41</NDC11Code>
<ProductNDC>0597-7705</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spevigo</ProprietaryName>
<NonProprietaryName>Spesolimab-sbzo</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250528</StartMarketingDate>
<EndMarketingDate>20270430</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761244</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SPESOLIMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250528</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.</IndicationAndUsage>
<Description>Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8.</Description>
</NDC>
<NDC>
<NDCCode>0597-7705-72</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0597-7705-72) / 300 INJECTION in 1 SYRINGE (0597-7705-38) </PackageDescription>
<NDC11Code>00597-7705-72</NDC11Code>
<ProductNDC>0597-7705</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spevigo</ProprietaryName>
<NonProprietaryName>Spesolimab-sbzo</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250528</StartMarketingDate>
<EndMarketingDate>20270430</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761244</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SPESOLIMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250528</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.</IndicationAndUsage>
<Description>Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8.</Description>
</NDC>
<NDC>
<NDCCode>50222-360-72</NDCCode>
<PackageDescription>2 VIAL, GLASS in 1 CARTON (50222-360-72) / 7.5 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>50222-0360-72</NDC11Code>
<ProductNDC>50222-360</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spevigo</ProprietaryName>
<NonProprietaryName>Spesolimab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260309</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761244</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>SPESOLIMAB</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.</IndicationAndUsage>
<Description>Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8.</Description>
</NDC>
<NDC>
<NDCCode>50222-361-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (50222-361-02) / 1 mL in 1 SYRINGE, GLASS (50222-361-11) </PackageDescription>
<NDC11Code>50222-0361-02</NDC11Code>
<ProductNDC>50222-361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spevigo</ProprietaryName>
<NonProprietaryName>Spesolimab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260309</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761244</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>SPESOLIMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.</IndicationAndUsage>
<Description>Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8.</Description>
</NDC>
<NDC>
<NDCCode>50222-362-01</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (50222-362-01) / 2 mL in 1 SYRINGE, GLASS (50222-362-12) </PackageDescription>
<NDC11Code>50222-0362-01</NDC11Code>
<ProductNDC>50222-362</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spevigo</ProprietaryName>
<NonProprietaryName>Spesolimab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260309</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761244</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>SPESOLIMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.</IndicationAndUsage>
<Description>Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8.</Description>
</NDC>
<NDC>
<NDCCode>50222-362-02</NDCCode>
<PackageDescription>2 SYRINGE, GLASS in 1 CARTON (50222-362-02) / 2 mL in 1 SYRINGE, GLASS (50222-362-12) </PackageDescription>
<NDC11Code>50222-0362-02</NDC11Code>
<ProductNDC>50222-362</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spevigo</ProprietaryName>
<NonProprietaryName>Spesolimab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260309</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761244</ApplicationNumber>
<LabelerName>LEO Pharma Inc.</LabelerName>
<SubstanceName>SPESOLIMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.</IndicationAndUsage>
<Description>Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8.</Description>
</NDC>
<NDC>
<NDCCode>59148-400-75</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (59148-400-75) / 2 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>59148-0400-75</NDC11Code>
<ProductNDC>59148-400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voyxact</ProprietaryName>
<NonProprietaryName>Sibeprenlimab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20251125</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761434</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>SIBEPRENLIMAB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.</IndicationAndUsage>
<Description>VOYXACT contains sibeprenlimab-szsi, an A Proliferation Inducing Ligand (APRIL) blocker and humanized immunoglobulin G2 (IgG2) monoclonal antibody produced by Chinese Hamster Ovary (CHO) cells. The approximate molecular weight of sibeprenlimab-szsi is 146 kDa. VOYXACT (sibeprenlimab-szsi) injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe delivers 400 mg sibeprenlimab-szsi and the inactive ingredients: arginine (17.6 mg), glutamic acid (14.8 mg), histidine (4.34 mg), L-histidine hydrochloride monohydrate (4.62 mg), polysorbate 80 (0.40 mg), sorbitol (36.4 mg), and Water for Injection, USP. The pH is 6.2.</Description>
</NDC>
<NDC>
<NDCCode>14445-001-01</NDCCode>
<PackageDescription>10 kg in 1 DRUM (14445-001-01) </PackageDescription>
<NDC11Code>14445-0001-01</NDC11Code>
<ProductNDC>14445-001</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20080115</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-03-12</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-JAN-08</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14445-001-02</NDCCode>
<PackageDescription>25 kg in 1 DRUM (14445-001-02) </PackageDescription>
<NDC11Code>14445-0001-02</NDC11Code>
<ProductNDC>14445-001</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20080115</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-03-12</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-JAN-08</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14445-001-03</NDCCode>
<PackageDescription>50 kg in 1 DRUM (14445-001-03) </PackageDescription>
<NDC11Code>14445-0001-03</NDC11Code>
<ProductNDC>14445-001</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20080115</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-03-12</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-JAN-08</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14445-002-01</NDCCode>
<PackageDescription>10 kg in 1 DRUM (14445-002-01) </PackageDescription>
<NDC11Code>14445-0002-01</NDC11Code>
<ProductNDC>14445-002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-07-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-DEC-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14445-002-02</NDCCode>
<PackageDescription>25 kg in 1 DRUM (14445-002-02) </PackageDescription>
<NDC11Code>14445-0002-02</NDC11Code>
<ProductNDC>14445-002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-07-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-DEC-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14445-002-03</NDCCode>
<PackageDescription>50 kg in 1 DRUM (14445-002-03) </PackageDescription>
<NDC11Code>14445-0002-03</NDC11Code>
<ProductNDC>14445-002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-07-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-DEC-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14445-002-04</NDCCode>
<PackageDescription>5 kg in 1 DRUM (14445-002-04) </PackageDescription>
<NDC11Code>14445-0002-04</NDC11Code>
<ProductNDC>14445-002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-07-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-MAR-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14445-002-05</NDCCode>
<PackageDescription>1 kg in 1 DRUM (14445-002-05) </PackageDescription>
<NDC11Code>14445-0002-05</NDC11Code>
<ProductNDC>14445-002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-07-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-MAR-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14445-002-06</NDCCode>
<PackageDescription>2 kg in 1 DRUM (14445-002-06) </PackageDescription>
<NDC11Code>14445-0002-06</NDC11Code>
<ProductNDC>14445-002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-07-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-MAR-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14445-002-07</NDCCode>
<PackageDescription>3 kg in 1 DRUM (14445-002-07) </PackageDescription>
<NDC11Code>14445-0002-07</NDC11Code>
<ProductNDC>14445-002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-07-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-MAR-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14445-002-08</NDCCode>
<PackageDescription>.5 kg in 1 DRUM (14445-002-08) </PackageDescription>
<NDC11Code>14445-0002-08</NDC11Code>
<ProductNDC>14445-002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-07-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-MAR-24</StartMarketingDatePackage>
</NDC>
</NDCList>