{
"NDC": [
{
"NDCCode": "80777-345-62",
"PackageDescription": "1 SYRINGE in 1 CARTON (80777-345-62) / .5 mL in 1 SYRINGE (80777-345-01) ",
"NDC11Code": "80777-0345-62",
"ProductNDC": "80777-345",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Mresvia",
"NonProprietaryName": "Respiratory Syncytial Virus Vaccine",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240531",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125796",
"LabelerName": "Moderna US, INC.",
"SubstanceName": "RNA-100-AR02",
"StrengthNumber": "50",
"StrengthUnit": "ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "MRESVIA is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in : 1 individuals 60 years of age and older., 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.",
"Description": "MRESVIA is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of MRESVIA contains 50 mcg of nucleoside modified mRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation (pre-F protein). Each 0.5 mL dose of MRESVIA also contains the following ingredients: a total lipid content of 1.02 mg (SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate), polyethylene glycol 2000 dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, 44 mg sucrose, and water for injection. MRESVIA does not contain a preservative. The rubber tip cap and plunger used for the pre-filled syringe are not made with natural rubber latex."
},
{
"NDCCode": "80777-400-62",
"PackageDescription": "1 SYRINGE, PLASTIC in 1 CARTON (80777-400-62) / .2 mL in 1 SYRINGE, PLASTIC (80777-400-17) ",
"NDC11Code": "80777-0400-62",
"ProductNDC": "80777-400",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Mnexspike",
"NonProprietaryName": "Covid-19 Vaccine, Mrna",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20250827",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125835",
"LabelerName": "Moderna US, Inc.",
"SubstanceName": "CX-052075",
"StrengthNumber": "10",
"StrengthUnit": "ug/.2mL",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250827",
"SamplePackage": "N",
"IndicationAndUsage": "MNEXSPIKE is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MNEXSPIKE is approved for use in individuals who are: 1 65 years of age and older, or, 2 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "MNEXSPIKE (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.2 mL dose of MNEXSPIKE (2025-2026 Formula) contains 10 mcg nucleoside-modified messenger RNA (mRNA) encoding the N-terminal domain (NTD) and receptor-binding domain (RBD) of the Spike glycoprotein of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 0.2 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.09 mg tromethamine, 0.51 mg tromethamine hydrochloride, and 17 mg sucrose. MNEXSPIKE does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex."
},
{
"NDCCode": "43744-345-62",
"PackageDescription": "2000 g in 1 DRUM (43744-345-62)",
"NDC11Code": "43744-0345-62",
"ProductNDC": "43744-345",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Enrofloxacin Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20111010",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "ENROFLOXACIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "51316-345-62",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (51316-345-62) / 6 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "51316-0345-62",
"ProductNDC": "51316-345",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus D",
"NonProprietaryName": "Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214407",
"LabelerName": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1200; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250404",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves nasal congestion due to. common cold. hay fever. upper respiratory allergies. temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage. temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "80777-345-61",
"PackageDescription": "10 SYRINGE in 1 CARTON (80777-345-61) / .5 mL in 1 SYRINGE (80777-345-01) ",
"NDC11Code": "80777-0345-61",
"ProductNDC": "80777-345",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Mresvia",
"NonProprietaryName": "Respiratory Syncytial Virus Vaccine",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240531",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125796",
"LabelerName": "Moderna US, INC.",
"SubstanceName": "RNA-100-AR02",
"StrengthNumber": "50",
"StrengthUnit": "ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "MRESVIA is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in : 1 individuals 60 years of age and older., 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.",
"Description": "MRESVIA is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of MRESVIA contains 50 mcg of nucleoside modified mRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation (pre-F protein). Each 0.5 mL dose of MRESVIA also contains the following ingredients: a total lipid content of 1.02 mg (SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate), polyethylene glycol 2000 dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, 44 mg sucrose, and water for injection. MRESVIA does not contain a preservative. The rubber tip cap and plunger used for the pre-filled syringe are not made with natural rubber latex."
},
{
"NDCCode": "80777-345-63",
"PackageDescription": "2 SYRINGE in 1 CARTON (80777-345-63) / .5 mL in 1 SYRINGE (80777-345-01) ",
"NDC11Code": "80777-0345-63",
"ProductNDC": "80777-345",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Mresvia",
"NonProprietaryName": "Respiratory Syncytial Virus Vaccine",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240531",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125796",
"LabelerName": "Moderna US, INC.",
"SubstanceName": "RNA-100-AR02",
"StrengthNumber": "50",
"StrengthUnit": "ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "MRESVIA is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in : 1 individuals 60 years of age and older., 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.",
"Description": "MRESVIA is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of MRESVIA contains 50 mcg of nucleoside modified mRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation (pre-F protein). Each 0.5 mL dose of MRESVIA also contains the following ingredients: a total lipid content of 1.02 mg (SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate), polyethylene glycol 2000 dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, 44 mg sucrose, and water for injection. MRESVIA does not contain a preservative. The rubber tip cap and plunger used for the pre-filled syringe are not made with natural rubber latex."
},
{
"NDCCode": "80777-345-89",
"PackageDescription": "2 SYRINGE in 1 CARTON (80777-345-89) / .5 mL in 1 SYRINGE (80777-345-01) ",
"NDC11Code": "80777-0345-89",
"ProductNDC": "80777-345",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Mresvia",
"NonProprietaryName": "Respiratory Syncytial Virus Vaccine",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240531",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125796",
"LabelerName": "Moderna US, INC.",
"SubstanceName": "RNA-100-AR02",
"StrengthNumber": "50",
"StrengthUnit": "ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "MRESVIA is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in : 1 individuals 60 years of age and older., 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.",
"Description": "MRESVIA is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of MRESVIA contains 50 mcg of nucleoside modified mRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation (pre-F protein). Each 0.5 mL dose of MRESVIA also contains the following ingredients: a total lipid content of 1.02 mg (SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate), polyethylene glycol 2000 dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, 44 mg sucrose, and water for injection. MRESVIA does not contain a preservative. The rubber tip cap and plunger used for the pre-filled syringe are not made with natural rubber latex."
},
{
"NDCCode": "80777-345-90",
"PackageDescription": "1 SYRINGE in 1 CARTON (80777-345-90) / .5 mL in 1 SYRINGE (80777-345-01) ",
"NDC11Code": "80777-0345-90",
"ProductNDC": "80777-345",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Mresvia",
"NonProprietaryName": "Respiratory Syncytial Virus Vaccine",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240531",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125796",
"LabelerName": "Moderna US, INC.",
"SubstanceName": "RNA-100-AR02",
"StrengthNumber": "50",
"StrengthUnit": "ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "MRESVIA is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in : 1 individuals 60 years of age and older., 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.",
"Description": "MRESVIA is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of MRESVIA contains 50 mcg of nucleoside modified mRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation (pre-F protein). Each 0.5 mL dose of MRESVIA also contains the following ingredients: a total lipid content of 1.02 mg (SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate), polyethylene glycol 2000 dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, 44 mg sucrose, and water for injection. MRESVIA does not contain a preservative. The rubber tip cap and plunger used for the pre-filled syringe are not made with natural rubber latex."
},
{
"NDCCode": "80777-345-96",
"PackageDescription": "10 SYRINGE in 1 CARTON (80777-345-96) / .5 mL in 1 SYRINGE (80777-345-01) ",
"NDC11Code": "80777-0345-96",
"ProductNDC": "80777-345",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Mresvia",
"NonProprietaryName": "Respiratory Syncytial Virus Vaccine",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240531",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125796",
"LabelerName": "Moderna US, INC.",
"SubstanceName": "RNA-100-AR02",
"StrengthNumber": "50",
"StrengthUnit": "ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "MRESVIA is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in : 1 individuals 60 years of age and older., 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.",
"Description": "MRESVIA is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of MRESVIA contains 50 mcg of nucleoside modified mRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation (pre-F protein). Each 0.5 mL dose of MRESVIA also contains the following ingredients: a total lipid content of 1.02 mg (SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate), polyethylene glycol 2000 dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, 44 mg sucrose, and water for injection. MRESVIA does not contain a preservative. The rubber tip cap and plunger used for the pre-filled syringe are not made with natural rubber latex."
},
{
"NDCCode": "80777-110-88",
"PackageDescription": "2 SYRINGE, PLASTIC in 1 CARTON (80777-110-88) / .5 mL in 1 SYRINGE, PLASTIC (80777-110-01) ",
"NDC11Code": "80777-0110-88",
"ProductNDC": "80777-110",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Spikevax",
"NonProprietaryName": "Covid-19 Vaccine, Mrna",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240815",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125752",
"LabelerName": "Moderna US, Inc.",
"SubstanceName": "CX-046684",
"StrengthNumber": "50",
"StrengthUnit": "ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240815",
"SamplePackage": "N",
"IndicationAndUsage": "SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2024-2025 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2024-2025 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex."
},
{
"NDCCode": "80777-110-93",
"PackageDescription": "10 SYRINGE, PLASTIC in 1 CARTON (80777-110-93) / .5 mL in 1 SYRINGE, PLASTIC (80777-110-01) ",
"NDC11Code": "80777-0110-93",
"ProductNDC": "80777-110",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Spikevax",
"NonProprietaryName": "Covid-19 Vaccine, Mrna",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240815",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125752",
"LabelerName": "Moderna US, Inc.",
"SubstanceName": "CX-046684",
"StrengthNumber": "50",
"StrengthUnit": "ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240815",
"SamplePackage": "N",
"IndicationAndUsage": "SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2024-2025 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2024-2025 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex."
},
{
"NDCCode": "80777-110-96",
"PackageDescription": "10 SYRINGE, PLASTIC in 1 CARTON (80777-110-96) / .5 mL in 1 SYRINGE, PLASTIC (80777-110-01) ",
"NDC11Code": "80777-0110-96",
"ProductNDC": "80777-110",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Spikevax",
"NonProprietaryName": "Covid-19 Vaccine, Mrna",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20240815",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125752",
"LabelerName": "Moderna US, Inc.",
"SubstanceName": "CX-046684",
"StrengthNumber": "50",
"StrengthUnit": "ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240815",
"SamplePackage": "N",
"IndicationAndUsage": "SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2024-2025 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2024-2025 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex."
},
{
"NDCCode": "80777-111-80",
"PackageDescription": "10 SYRINGE, PLASTIC in 1 CARTON (80777-111-80) / .25 mL in 1 SYRINGE, PLASTIC (80777-111-09) ",
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"IndicationAndUsage": "SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2024-2025 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2024-2025 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex."
},
{
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"IndicationAndUsage": "SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2024-2025 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2024-2025 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex."
},
{
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"PackageDescription": "2 SYRINGE, PLASTIC in 1 CARTON (80777-112-88) / .5 mL in 1 SYRINGE, PLASTIC (80777-112-01) ",
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"ProductTypeName": "VACCINE",
"ProprietaryName": "Spikevax",
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"RouteName": "INTRAMUSCULAR",
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"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125752",
"LabelerName": "Moderna US, Inc.",
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"IndicationAndUsage": "SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2025-2026 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2025-2026 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex."
},
{
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"ProductNDC": "80777-112",
"ProductTypeName": "VACCINE",
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"RouteName": "INTRAMUSCULAR",
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"MarketingCategoryName": "BLA",
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"LabelerName": "Moderna US, Inc.",
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"IndicationAndUsage": "SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2025-2026 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2025-2026 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex."
},
{
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"ProductTypeName": "VACCINE",
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"RouteName": "INTRAMUSCULAR",
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"LabelerName": "Moderna US, Inc.",
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"StrengthNumber": "50",
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"LastUpdate": "2026-08-31",
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"IndicationAndUsage": "SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2025-2026 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2025-2026 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex."
},
{
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"RouteName": "INTRAMUSCULAR",
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"LabelerName": "Moderna US, Inc.",
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"IndicationAndUsage": "SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2025-2026 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2025-2026 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex."
},
{
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"LabelerName": "Moderna US, Inc.",
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"IndicationAndUsage": "SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2025-2026 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2025-2026 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex."
},
{
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"ProductTypeName": "VACCINE",
"ProprietaryName": "Spikevax",
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"LabelerName": "Moderna US, Inc.",
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"StrengthNumber": "50",
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"LastUpdate": "2026-08-31",
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"IndicationAndUsage": "SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2026-2027 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of the SARS-CoV-2 JN.1-descendent variant XFG. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2026-2027 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of the SARS-CoV-2 JN.1-descendent variant XFG. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex."
},
{
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"ProprietaryName": "Spikevax",
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"LabelerName": "Moderna US, Inc.",
"SubstanceName": "CX-055611",
"StrengthNumber": "25",
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"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.",
"Description": "SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2026-2027 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of the SARS-CoV-2 JN.1-descendent variant XFG. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2026-2027 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of the SARS-CoV-2 JN.1-descendent variant XFG. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex."
},
{
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20040427",
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"IndicationAndUsage": "Methadone hydrochloride tablets are indicated for the. 1.Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including methadone hydrochloride tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain [see Warnings and Precautions (5.1)]. .",
"Description": "Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a white powder. Its molecular formula is C21H27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Methadone Hydrochloride Tablets are available for oral administration containing either 5 mg or 10 mg of methadone hydrochloride USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide."
},
{
"NDCCode": "0406-5771-62",
"PackageDescription": "100 TABLET in 1 BLISTER PACK (0406-5771-62) ",
"NDC11Code": "00406-5771-62",
"ProductNDC": "0406-5771",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
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"RouteName": "ORAL",
"StartMarketingDate": "20040427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040517",
"LabelerName": "SpecGx LLC",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20040427",
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"IndicationAndUsage": "Methadone hydrochloride tablets are indicated for the. 1.Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including methadone hydrochloride tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain [see Warnings and Precautions (5.1)]. .",
"Description": "Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a white powder. Its molecular formula is C21H27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Methadone Hydrochloride Tablets are available for oral administration containing either 5 mg or 10 mg of methadone hydrochloride USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide."
},
{
"NDCCode": "27241-029-62",
"PackageDescription": "1 FOR SUSPENSION in 1 PACKET (27241-029-62) ",
"NDC11Code": "27241-0029-62",
"ProductNDC": "27241-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole And Sodium Bicarbonate",
"NonProprietaryName": "Omeprazole And Sodium Bicarbonate",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20160727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205545",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "OMEPRAZOLE; SODIUM BICARBONATE",
"StrengthNumber": "20; 1680",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Alkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20160727",
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"IndicationAndUsage": "Omeprazole and Sodium Bicarbonate for oral suspension is indicated in adults for the: 1 short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy., 2 short-term treatment (4 to 8 weeks) of active benign gastric ulcer., 3 treatment of heartburn and other symptoms associated with GERD for up to 4 weeks., 4 short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.The efficacy of Omeprazole and Sodium Bicarbonate used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Omeprazole and Sodium Bicarbonate may be considered., 5 maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.",
"Description": "Omeprazole and Sodium Bicarbonate for oral suspension is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions. Omeprazole and Sodium Bicarbonate for oral suspension are supplied as immediate-release unit-dose packets as powder for oral suspension. Packets of powder for oral suspension contain either 40 mg or 20 mg of omeprazole USP and 1,680 mg of sodium bicarbonate USP with the following excipients: xylitol, sucralose, xanthan gum, colloidal silicon dioxide and flavorings. Omeprazole and Sodium Bicarbonate for oral suspension is immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation."
},
{
"NDCCode": "27241-030-62",
"PackageDescription": "1 FOR SUSPENSION in 1 PACKET (27241-030-62) ",
"NDC11Code": "27241-0030-62",
"ProductNDC": "27241-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole And Sodium Bicarbonate",
"NonProprietaryName": "Omeprazole And Sodium Bicarbonate",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20160727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205545",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "OMEPRAZOLE; SODIUM BICARBONATE",
"StrengthNumber": "40; 1680",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Alkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160727",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole and Sodium Bicarbonate for oral suspension is indicated in adults for the: 1 short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy., 2 short-term treatment (4 to 8 weeks) of active benign gastric ulcer., 3 treatment of heartburn and other symptoms associated with GERD for up to 4 weeks., 4 short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.The efficacy of Omeprazole and Sodium Bicarbonate used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Omeprazole and Sodium Bicarbonate may be considered., 5 maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.",
"Description": "Omeprazole and Sodium Bicarbonate for oral suspension is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions. Omeprazole and Sodium Bicarbonate for oral suspension are supplied as immediate-release unit-dose packets as powder for oral suspension. Packets of powder for oral suspension contain either 40 mg or 20 mg of omeprazole USP and 1,680 mg of sodium bicarbonate USP with the following excipients: xylitol, sucralose, xanthan gum, colloidal silicon dioxide and flavorings. Omeprazole and Sodium Bicarbonate for oral suspension is immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation."
},
{
"NDCCode": "43547-518-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (43547-518-10) ",
"NDC11Code": "43547-0518-10",
"ProductNDC": "43547-518",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206954",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20220412",
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"IndicationAndUsage": "Quetiapine tablets are atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP, are supplied for oral administration as 25 mg (round, pink), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, fumaric acid, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium starch glycolate, talc, titanium dioxide. The 25 mg tablets contain iron oxide red and lecithin (soya). The 50 mg, 200 mg and 300 mg tablets contain lecithin (soya). The 100 mg and 400 mg tablets contain D&C yellow #10 aluminum lake and iron oxide red. Each 25 mg tablet contains 28.8 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.62 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.25 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.50 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.75 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461.00 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "43547-518-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (43547-518-11) ",
"NDC11Code": "43547-0518-11",
"ProductNDC": "43547-518",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206954",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Quetiapine tablets are atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP, are supplied for oral administration as 25 mg (round, pink), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, fumaric acid, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium starch glycolate, talc, titanium dioxide. The 25 mg tablets contain iron oxide red and lecithin (soya). The 50 mg, 200 mg and 300 mg tablets contain lecithin (soya). The 100 mg and 400 mg tablets contain D&C yellow #10 aluminum lake and iron oxide red. Each 25 mg tablet contains 28.8 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.62 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.25 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.50 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.75 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461.00 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "43547-519-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (43547-519-10) ",
"NDC11Code": "43547-0519-10",
"ProductNDC": "43547-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206954",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20220412",
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"IndicationAndUsage": "Quetiapine tablets are atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP, are supplied for oral administration as 25 mg (round, pink), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, fumaric acid, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium starch glycolate, talc, titanium dioxide. The 25 mg tablets contain iron oxide red and lecithin (soya). The 50 mg, 200 mg and 300 mg tablets contain lecithin (soya). The 100 mg and 400 mg tablets contain D&C yellow #10 aluminum lake and iron oxide red. Each 25 mg tablet contains 28.8 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.62 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.25 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.50 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.75 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461.00 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "43547-519-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (43547-519-11) ",
"NDC11Code": "43547-0519-11",
"ProductNDC": "43547-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206954",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "50",
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"Pharm_Classes": "Atypical Antipsychotic [EPC]",
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"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Quetiapine tablets are atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP, are supplied for oral administration as 25 mg (round, pink), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, fumaric acid, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium starch glycolate, talc, titanium dioxide. The 25 mg tablets contain iron oxide red and lecithin (soya). The 50 mg, 200 mg and 300 mg tablets contain lecithin (soya). The 100 mg and 400 mg tablets contain D&C yellow #10 aluminum lake and iron oxide red. Each 25 mg tablet contains 28.8 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.62 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.25 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.50 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.75 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461.00 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "43547-520-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (43547-520-10) ",
"NDC11Code": "43547-0520-10",
"ProductNDC": "43547-520",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206954",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablets are atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP, are supplied for oral administration as 25 mg (round, pink), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, fumaric acid, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium starch glycolate, talc, titanium dioxide. The 25 mg tablets contain iron oxide red and lecithin (soya). The 50 mg, 200 mg and 300 mg tablets contain lecithin (soya). The 100 mg and 400 mg tablets contain D&C yellow #10 aluminum lake and iron oxide red. Each 25 mg tablet contains 28.8 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.62 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.25 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.50 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.75 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461.00 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
}
]
}
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<PackageDescription>1 SYRINGE in 1 CARTON (80777-345-62) / .5 mL in 1 SYRINGE (80777-345-01) </PackageDescription>
<NDC11Code>80777-0345-62</NDC11Code>
<ProductNDC>80777-345</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
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<LabelerName>Moderna US, INC.</LabelerName>
<SubstanceName>RNA-100-AR02</SubstanceName>
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<StrengthUnit>ug/.5mL</StrengthUnit>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MRESVIA is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in : 1 individuals 60 years of age and older., 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.</IndicationAndUsage>
<Description>MRESVIA is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of MRESVIA contains 50 mcg of nucleoside modified mRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation (pre-F protein). Each 0.5 mL dose of MRESVIA also contains the following ingredients: a total lipid content of 1.02 mg (SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate), polyethylene glycol 2000 dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, 44 mg sucrose, and water for injection. MRESVIA does not contain a preservative. The rubber tip cap and plunger used for the pre-filled syringe are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>80777-400-62</NDCCode>
<PackageDescription>1 SYRINGE, PLASTIC in 1 CARTON (80777-400-62) / .2 mL in 1 SYRINGE, PLASTIC (80777-400-17) </PackageDescription>
<NDC11Code>80777-0400-62</NDC11Code>
<ProductNDC>80777-400</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Mnexspike</ProprietaryName>
<NonProprietaryName>Covid-19 Vaccine, Mrna</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20250827</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125835</ApplicationNumber>
<LabelerName>Moderna US, Inc.</LabelerName>
<SubstanceName>CX-052075</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MNEXSPIKE is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MNEXSPIKE is approved for use in individuals who are: 1 65 years of age and older, or, 2 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>MNEXSPIKE (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.2 mL dose of MNEXSPIKE (2025-2026 Formula) contains 10 mcg nucleoside-modified messenger RNA (mRNA) encoding the N-terminal domain (NTD) and receptor-binding domain (RBD) of the Spike glycoprotein of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 0.2 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.09 mg tromethamine, 0.51 mg tromethamine hydrochloride, and 17 mg sucrose. MNEXSPIKE does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>43744-345-62</NDCCode>
<PackageDescription>2000 g in 1 DRUM (43744-345-62)</PackageDescription>
<NDC11Code>43744-0345-62</NDC11Code>
<ProductNDC>43744-345</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Enrofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20111010</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>ENROFLOXACIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51316-345-62</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (51316-345-62) / 6 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51316-0345-62</NDC11Code>
<ProductNDC>51316-345</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus D</ProprietaryName>
<NonProprietaryName>Guaifenesin, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214407</ApplicationNumber>
<LabelerName>CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED</LabelerName>
<SubstanceName>GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1200; 120</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves nasal congestion due to. common cold. hay fever. upper respiratory allergies. temporarily restores freer breathing through the nose. promotes nasal and/or sinus drainage. temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80777-345-61</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (80777-345-61) / .5 mL in 1 SYRINGE (80777-345-01) </PackageDescription>
<NDC11Code>80777-0345-61</NDC11Code>
<ProductNDC>80777-345</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Mresvia</ProprietaryName>
<NonProprietaryName>Respiratory Syncytial Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240531</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125796</ApplicationNumber>
<LabelerName>Moderna US, INC.</LabelerName>
<SubstanceName>RNA-100-AR02</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MRESVIA is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in : 1 individuals 60 years of age and older., 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.</IndicationAndUsage>
<Description>MRESVIA is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of MRESVIA contains 50 mcg of nucleoside modified mRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation (pre-F protein). Each 0.5 mL dose of MRESVIA also contains the following ingredients: a total lipid content of 1.02 mg (SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate), polyethylene glycol 2000 dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, 44 mg sucrose, and water for injection. MRESVIA does not contain a preservative. The rubber tip cap and plunger used for the pre-filled syringe are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>80777-345-63</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (80777-345-63) / .5 mL in 1 SYRINGE (80777-345-01) </PackageDescription>
<NDC11Code>80777-0345-63</NDC11Code>
<ProductNDC>80777-345</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Mresvia</ProprietaryName>
<NonProprietaryName>Respiratory Syncytial Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240531</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125796</ApplicationNumber>
<LabelerName>Moderna US, INC.</LabelerName>
<SubstanceName>RNA-100-AR02</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MRESVIA is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in : 1 individuals 60 years of age and older., 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.</IndicationAndUsage>
<Description>MRESVIA is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of MRESVIA contains 50 mcg of nucleoside modified mRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation (pre-F protein). Each 0.5 mL dose of MRESVIA also contains the following ingredients: a total lipid content of 1.02 mg (SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate), polyethylene glycol 2000 dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, 44 mg sucrose, and water for injection. MRESVIA does not contain a preservative. The rubber tip cap and plunger used for the pre-filled syringe are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>80777-345-89</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (80777-345-89) / .5 mL in 1 SYRINGE (80777-345-01) </PackageDescription>
<NDC11Code>80777-0345-89</NDC11Code>
<ProductNDC>80777-345</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Mresvia</ProprietaryName>
<NonProprietaryName>Respiratory Syncytial Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240531</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125796</ApplicationNumber>
<LabelerName>Moderna US, INC.</LabelerName>
<SubstanceName>RNA-100-AR02</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MRESVIA is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in : 1 individuals 60 years of age and older., 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.</IndicationAndUsage>
<Description>MRESVIA is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of MRESVIA contains 50 mcg of nucleoside modified mRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation (pre-F protein). Each 0.5 mL dose of MRESVIA also contains the following ingredients: a total lipid content of 1.02 mg (SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate), polyethylene glycol 2000 dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, 44 mg sucrose, and water for injection. MRESVIA does not contain a preservative. The rubber tip cap and plunger used for the pre-filled syringe are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>80777-345-90</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (80777-345-90) / .5 mL in 1 SYRINGE (80777-345-01) </PackageDescription>
<NDC11Code>80777-0345-90</NDC11Code>
<ProductNDC>80777-345</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Mresvia</ProprietaryName>
<NonProprietaryName>Respiratory Syncytial Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240531</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125796</ApplicationNumber>
<LabelerName>Moderna US, INC.</LabelerName>
<SubstanceName>RNA-100-AR02</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MRESVIA is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in : 1 individuals 60 years of age and older., 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.</IndicationAndUsage>
<Description>MRESVIA is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of MRESVIA contains 50 mcg of nucleoside modified mRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation (pre-F protein). Each 0.5 mL dose of MRESVIA also contains the following ingredients: a total lipid content of 1.02 mg (SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate), polyethylene glycol 2000 dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, 44 mg sucrose, and water for injection. MRESVIA does not contain a preservative. The rubber tip cap and plunger used for the pre-filled syringe are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>80777-345-96</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (80777-345-96) / .5 mL in 1 SYRINGE (80777-345-01) </PackageDescription>
<NDC11Code>80777-0345-96</NDC11Code>
<ProductNDC>80777-345</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Mresvia</ProprietaryName>
<NonProprietaryName>Respiratory Syncytial Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240531</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125796</ApplicationNumber>
<LabelerName>Moderna US, INC.</LabelerName>
<SubstanceName>RNA-100-AR02</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MRESVIA is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in : 1 individuals 60 years of age and older., 2 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.</IndicationAndUsage>
<Description>MRESVIA is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of MRESVIA contains 50 mcg of nucleoside modified mRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation (pre-F protein). Each 0.5 mL dose of MRESVIA also contains the following ingredients: a total lipid content of 1.02 mg (SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate), polyethylene glycol 2000 dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, 44 mg sucrose, and water for injection. MRESVIA does not contain a preservative. The rubber tip cap and plunger used for the pre-filled syringe are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>80777-110-88</NDCCode>
<PackageDescription>2 SYRINGE, PLASTIC in 1 CARTON (80777-110-88) / .5 mL in 1 SYRINGE, PLASTIC (80777-110-01) </PackageDescription>
<NDC11Code>80777-0110-88</NDC11Code>
<ProductNDC>80777-110</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Spikevax</ProprietaryName>
<NonProprietaryName>Covid-19 Vaccine, Mrna</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240815</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125752</ApplicationNumber>
<LabelerName>Moderna US, Inc.</LabelerName>
<SubstanceName>CX-046684</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2024-2025 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2024-2025 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>80777-110-93</NDCCode>
<PackageDescription>10 SYRINGE, PLASTIC in 1 CARTON (80777-110-93) / .5 mL in 1 SYRINGE, PLASTIC (80777-110-01) </PackageDescription>
<NDC11Code>80777-0110-93</NDC11Code>
<ProductNDC>80777-110</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Spikevax</ProprietaryName>
<NonProprietaryName>Covid-19 Vaccine, Mrna</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240815</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125752</ApplicationNumber>
<LabelerName>Moderna US, Inc.</LabelerName>
<SubstanceName>CX-046684</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2024-2025 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2024-2025 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>80777-110-96</NDCCode>
<PackageDescription>10 SYRINGE, PLASTIC in 1 CARTON (80777-110-96) / .5 mL in 1 SYRINGE, PLASTIC (80777-110-01) </PackageDescription>
<NDC11Code>80777-0110-96</NDC11Code>
<ProductNDC>80777-110</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Spikevax</ProprietaryName>
<NonProprietaryName>Covid-19 Vaccine, Mrna</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20240815</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125752</ApplicationNumber>
<LabelerName>Moderna US, Inc.</LabelerName>
<SubstanceName>CX-046684</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2024-2025 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2024-2025 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
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<NDC>
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<LabelerName>Moderna US, Inc.</LabelerName>
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<IndicationAndUsage>SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2024-2025 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2024-2025 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
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<LabelerName>Moderna US, Inc.</LabelerName>
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<LastUpdate>2025-09-02</LastUpdate>
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<IndicationAndUsage>SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2024-2025 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2024-2025 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage KP.2. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
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<LabelerName>Moderna US, Inc.</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2026-08-31</LastUpdate>
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<IndicationAndUsage>SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2025-2026 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2025-2026 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
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<ApplicationNumber>BLA125752</ApplicationNumber>
<LabelerName>Moderna US, Inc.</LabelerName>
<SubstanceName>CX-051869</SubstanceName>
<StrengthNumber>50</StrengthNumber>
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<Status>Deprecated</Status>
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<IndicationAndUsage>SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2025-2026 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2025-2026 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
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<RouteName>INTRAMUSCULAR</RouteName>
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<ApplicationNumber>BLA125752</ApplicationNumber>
<LabelerName>Moderna US, Inc.</LabelerName>
<SubstanceName>CX-051869</SubstanceName>
<StrengthNumber>50</StrengthNumber>
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<Status>Deprecated</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2025-2026 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2025-2026 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
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<LabelerName>Moderna US, Inc.</LabelerName>
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<IndicationAndUsage>SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2025-2026 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2025-2026 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
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<LabelerName>Moderna US, Inc.</LabelerName>
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<IndicationAndUsage>SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2025-2026 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2025-2026 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant sublineage LP.8.1. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
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<LabelerName>Moderna US, Inc.</LabelerName>
<SubstanceName>CX-055611</SubstanceName>
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<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2026-2027 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of the SARS-CoV-2 JN.1-descendent variant XFG. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2026-2027 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of the SARS-CoV-2 JN.1-descendent variant XFG. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>80777-115-80</NDCCode>
<PackageDescription>10 SYRINGE, PLASTIC in 1 CARTON (80777-115-80) / .25 mL in 1 SYRINGE, PLASTIC (80777-115-09) </PackageDescription>
<NDC11Code>80777-0115-80</NDC11Code>
<ProductNDC>80777-115</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Spikevax</ProprietaryName>
<NonProprietaryName>Covid-19 Vaccine, Mrna</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20260817</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125752</ApplicationNumber>
<LabelerName>Moderna US, Inc.</LabelerName>
<SubstanceName>CX-055611</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/.25mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SPIKEVAX is approved for use in individuals who are: 1 65 years of age and older, or, 2 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.</IndicationAndUsage>
<Description>SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white injectable suspension for intramuscular use. Each 0.5 mL dose of SPIKEVAX (2026-2027 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of the SARS-CoV-2 JN.1-descendent variant XFG. Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. Each 0.25 mL dose of SPIKEVAX (2026-2027 Formula) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of the SARS-CoV-2 JN.1-descendent variant XFG. Each dose also contains the following ingredients: a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium acetate trihydrate, and 21.8 mg sucrose. SPIKEVAX does not contain a preservative. The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>0406-5755-62</NDCCode>
<PackageDescription>100 TABLET in 1 BLISTER PACK (0406-5755-62) </PackageDescription>
<NDC11Code>00406-5755-62</NDC11Code>
<ProductNDC>0406-5755</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040517</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methadone hydrochloride tablets are indicated for the. 1.Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including methadone hydrochloride tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain [see Warnings and Precautions (5.1)]. .</IndicationAndUsage>
<Description>Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a white powder. Its molecular formula is C21H27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Methadone Hydrochloride Tablets are available for oral administration containing either 5 mg or 10 mg of methadone hydrochloride USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0406-5771-62</NDCCode>
<PackageDescription>100 TABLET in 1 BLISTER PACK (0406-5771-62) </PackageDescription>
<NDC11Code>00406-5771-62</NDC11Code>
<ProductNDC>0406-5771</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040517</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methadone hydrochloride tablets are indicated for the. 1.Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including methadone hydrochloride tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain [see Warnings and Precautions (5.1)]. .</IndicationAndUsage>
<Description>Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a white powder. Its molecular formula is C21H27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Methadone Hydrochloride Tablets are available for oral administration containing either 5 mg or 10 mg of methadone hydrochloride USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>27241-029-62</NDCCode>
<PackageDescription>1 FOR SUSPENSION in 1 PACKET (27241-029-62) </PackageDescription>
<NDC11Code>27241-0029-62</NDC11Code>
<ProductNDC>27241-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole And Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Omeprazole And Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205545</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>OMEPRAZOLE; SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>20; 1680</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Alkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole and Sodium Bicarbonate for oral suspension is indicated in adults for the: 1 short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy., 2 short-term treatment (4 to 8 weeks) of active benign gastric ulcer., 3 treatment of heartburn and other symptoms associated with GERD for up to 4 weeks., 4 short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.The efficacy of Omeprazole and Sodium Bicarbonate used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Omeprazole and Sodium Bicarbonate may be considered., 5 maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.</IndicationAndUsage>
<Description>Omeprazole and Sodium Bicarbonate for oral suspension is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions. Omeprazole and Sodium Bicarbonate for oral suspension are supplied as immediate-release unit-dose packets as powder for oral suspension. Packets of powder for oral suspension contain either 40 mg or 20 mg of omeprazole USP and 1,680 mg of sodium bicarbonate USP with the following excipients: xylitol, sucralose, xanthan gum, colloidal silicon dioxide and flavorings. Omeprazole and Sodium Bicarbonate for oral suspension is immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation.</Description>
</NDC>
<NDC>
<NDCCode>27241-030-62</NDCCode>
<PackageDescription>1 FOR SUSPENSION in 1 PACKET (27241-030-62) </PackageDescription>
<NDC11Code>27241-0030-62</NDC11Code>
<ProductNDC>27241-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole And Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Omeprazole And Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205545</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>OMEPRAZOLE; SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>40; 1680</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Alkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole and Sodium Bicarbonate for oral suspension is indicated in adults for the: 1 short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy., 2 short-term treatment (4 to 8 weeks) of active benign gastric ulcer., 3 treatment of heartburn and other symptoms associated with GERD for up to 4 weeks., 4 short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.The efficacy of Omeprazole and Sodium Bicarbonate used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Omeprazole and Sodium Bicarbonate may be considered., 5 maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.</IndicationAndUsage>
<Description>Omeprazole and Sodium Bicarbonate for oral suspension is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions. Omeprazole and Sodium Bicarbonate for oral suspension are supplied as immediate-release unit-dose packets as powder for oral suspension. Packets of powder for oral suspension contain either 40 mg or 20 mg of omeprazole USP and 1,680 mg of sodium bicarbonate USP with the following excipients: xylitol, sucralose, xanthan gum, colloidal silicon dioxide and flavorings. Omeprazole and Sodium Bicarbonate for oral suspension is immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation.</Description>
</NDC>
<NDC>
<NDCCode>43547-518-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (43547-518-10) </PackageDescription>
<NDC11Code>43547-0518-10</NDC11Code>
<ProductNDC>43547-518</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206954</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP, are supplied for oral administration as 25 mg (round, pink), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, fumaric acid, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium starch glycolate, talc, titanium dioxide. The 25 mg tablets contain iron oxide red and lecithin (soya). The 50 mg, 200 mg and 300 mg tablets contain lecithin (soya). The 100 mg and 400 mg tablets contain D&C yellow #10 aluminum lake and iron oxide red. Each 25 mg tablet contains 28.8 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.62 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.25 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.50 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.75 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461.00 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>43547-518-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (43547-518-11) </PackageDescription>
<NDC11Code>43547-0518-11</NDC11Code>
<ProductNDC>43547-518</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206954</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP, are supplied for oral administration as 25 mg (round, pink), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, fumaric acid, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium starch glycolate, talc, titanium dioxide. The 25 mg tablets contain iron oxide red and lecithin (soya). The 50 mg, 200 mg and 300 mg tablets contain lecithin (soya). The 100 mg and 400 mg tablets contain D&C yellow #10 aluminum lake and iron oxide red. Each 25 mg tablet contains 28.8 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.62 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.25 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.50 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.75 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461.00 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>43547-519-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (43547-519-10) </PackageDescription>
<NDC11Code>43547-0519-10</NDC11Code>
<ProductNDC>43547-519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206954</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP, are supplied for oral administration as 25 mg (round, pink), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, fumaric acid, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium starch glycolate, talc, titanium dioxide. The 25 mg tablets contain iron oxide red and lecithin (soya). The 50 mg, 200 mg and 300 mg tablets contain lecithin (soya). The 100 mg and 400 mg tablets contain D&C yellow #10 aluminum lake and iron oxide red. Each 25 mg tablet contains 28.8 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.62 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.25 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.50 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.75 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461.00 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
</NDC>
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<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206954</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP, are supplied for oral administration as 25 mg (round, pink), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, fumaric acid, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium starch glycolate, talc, titanium dioxide. The 25 mg tablets contain iron oxide red and lecithin (soya). The 50 mg, 200 mg and 300 mg tablets contain lecithin (soya). The 100 mg and 400 mg tablets contain D&C yellow #10 aluminum lake and iron oxide red. Each 25 mg tablet contains 28.8 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.62 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.25 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.50 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.75 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461.00 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
</NDC>
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<NDCCode>43547-520-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (43547-520-10) </PackageDescription>
<NDC11Code>43547-0520-10</NDC11Code>
<ProductNDC>43547-520</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206954</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
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<StartMarketingDatePackage>20220412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP, are supplied for oral administration as 25 mg (round, pink), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, fumaric acid, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium starch glycolate, talc, titanium dioxide. The 25 mg tablets contain iron oxide red and lecithin (soya). The 50 mg, 200 mg and 300 mg tablets contain lecithin (soya). The 100 mg and 400 mg tablets contain D&C yellow #10 aluminum lake and iron oxide red. Each 25 mg tablet contains 28.8 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.62 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.25 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.50 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.75 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461.00 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
</NDC>
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