{
"NDC": [
{
"NDCCode": "43598-054-89",
"PackageDescription": "1500 TABLET in 1 POUCH (43598-054-89) ",
"NDC11Code": "43598-0054-89",
"ProductNDC": "43598-054",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET",
"StartMarketingDate": "20220110",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "10-JAN-22"
},
{
"NDCCode": "43598-008-89",
"PackageDescription": "1280 TABLET, EXTENDED RELEASE in 1 CASE (43598-008-89) ",
"NDC11Code": "43598-0008-89",
"ProductNDC": "43598-008",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-07-30",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "18-JUL-23"
},
{
"NDCCode": "43598-408-89",
"PackageDescription": "1500 CAPSULE, DELAYED RELEASE in 1 POUCH (43598-408-89)",
"NDC11Code": "43598-0408-89",
"ProductNDC": "43598-408",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Omeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"StartMarketingDate": "20150102",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "43598-577-89",
"PackageDescription": "1500 TABLET in 1 POUCH (43598-577-89) ",
"NDC11Code": "43598-0577-89",
"ProductNDC": "43598-577",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET",
"StartMarketingDate": "20160725",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2023-01-16",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "25-JUL-16"
},
{
"NDCCode": "43598-086-58",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (43598-086-58) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "43598-0086-58",
"ProductNDC": "43598-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"ProprietaryNameSuffix": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218753",
"LabelerName": "Dr. Reddy's Laboratories, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250718",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline for injection and other antibacterial drugs, doxycycline for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated in infections caused by the following microorganisms: 1 Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, , 2 Q fever, rickettsial pox and tick fevers)., 3 Mycoplasma pneumoniae (PPLO, Eaton Agent). , 4 Agents of psittacosis and ornithosis., 5 Agents of lymphogranuloma venereum and granuloma inguinale., 6 The spirochetal agent of relapsing fever (Borrelia recurrentis).",
"Description": "Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, USP, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate, USP is a broad spectrum antibiotic derived from oxytetracycline. It is meant for INTRAVENOUS use only after reconstitution. Doxycycline hyclate, USP is a yellow to light yellow powder which is chemically designated 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11- dioxo-2-naphthacenecarboxamide, monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. It has the following structural formula. (C22H24N2O8·HCl)2·C2H6O·H2O M.W.1025.89. Doxycycline hyclate, USP is soluble in water and chars at 201°C without melting. The base doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Each 100 mg vial contains: Doxycycline hyclate, USP equivalent to 100 mg doxycycline; ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3."
},
{
"NDCCode": "43598-975-58",
"PackageDescription": "10 VIAL in 1 CARTON (43598-975-58) / 100 mL in 1 VIAL (43598-975-11) ",
"NDC11Code": "43598-0975-58",
"ProductNDC": "43598-975",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209307",
"LabelerName": "Dr.Reddy's Laboratories Inc",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200817",
"SamplePackage": "N",
"Description": "Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride, USP is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride, USP has a molecular weight of 236.7 and the empirical formula is C13H16N2HCl and the structural formula is. Dexmedetomidine hydrochloride, USP is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride, USP equivalent to 4 mcg (0.004 mg) of dexmedetomidine and 9 mg sodium chloride in water and is ready to be used. The solution is preservative-free and contains no additives or chemical stabilizers."
},
{
"NDCCode": "43598-976-58",
"PackageDescription": "10 VIAL in 1 CARTON (43598-976-58) / 50 mL in 1 VIAL (43598-976-11) ",
"NDC11Code": "43598-0976-58",
"ProductNDC": "43598-976",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209307",
"LabelerName": "Dr.Reddy's Laboratories Inc",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200817",
"SamplePackage": "N",
"Description": "Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride, USP is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride, USP has a molecular weight of 236.7 and the empirical formula is C13H16N2HCl and the structural formula is. Dexmedetomidine hydrochloride, USP is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride, USP equivalent to 4 mcg (0.004 mg) of dexmedetomidine and 9 mg sodium chloride in water and is ready to be used. The solution is preservative-free and contains no additives or chemical stabilizers."
},
{
"NDCCode": "43598-001-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-10) ",
"NDC11Code": "43598-0001-10",
"ProductNDC": "43598-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078421",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP."
},
{
"NDCCode": "43598-001-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-30) ",
"NDC11Code": "43598-0001-30",
"ProductNDC": "43598-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078421",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP."
},
{
"NDCCode": "43598-001-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-90) ",
"NDC11Code": "43598-0001-90",
"ProductNDC": "43598-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078421",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP."
},
{
"NDCCode": "43598-002-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-05) ",
"NDC11Code": "43598-0002-05",
"ProductNDC": "43598-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078421",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP."
},
{
"NDCCode": "43598-002-10",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-10) ",
"NDC11Code": "43598-0002-10",
"ProductNDC": "43598-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078421",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP."
},
{
"NDCCode": "43598-002-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-30) ",
"NDC11Code": "43598-0002-30",
"ProductNDC": "43598-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078421",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP."
},
{
"NDCCode": "43598-002-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-90) ",
"NDC11Code": "43598-0002-90",
"ProductNDC": "43598-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078421",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP."
},
{
"NDCCode": "43598-003-51",
"PackageDescription": "75 mL in 1 BOTTLE (43598-003-51)",
"NDC11Code": "43598-0003-51",
"ProductNDC": "43598-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin Es-600",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20121031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050755",
"LabelerName": "Dr Reddys Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.",
"Description": "AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as."
},
{
"NDCCode": "43598-003-54",
"PackageDescription": "200 mL in 1 BOTTLE (43598-003-54)",
"NDC11Code": "43598-0003-54",
"ProductNDC": "43598-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin Es-600",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20121031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050755",
"LabelerName": "Dr Reddys Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.",
"Description": "AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as."
},
{
"NDCCode": "43598-003-69",
"PackageDescription": "125 mL in 1 BOTTLE (43598-003-69)",
"NDC11Code": "43598-0003-69",
"ProductNDC": "43598-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin Es-600",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20121031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050755",
"LabelerName": "Dr Reddys Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.",
"Description": "AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as."
},
{
"NDCCode": "43598-004-51",
"PackageDescription": "75 mL in 1 BOTTLE (43598-004-51)",
"NDC11Code": "43598-0004-51",
"ProductNDC": "43598-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19901022",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050575",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "250; 62.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"Description": "AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of AUGMENTIN contains 0.63 mEq potassium."
},
{
"NDCCode": "43598-004-52",
"PackageDescription": "100 mL in 1 BOTTLE (43598-004-52)",
"NDC11Code": "43598-0004-52",
"ProductNDC": "43598-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19901022",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050575",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "250; 62.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"Description": "AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of AUGMENTIN contains 0.63 mEq potassium."
},
{
"NDCCode": "43598-004-53",
"PackageDescription": "150 mL in 1 BOTTLE (43598-004-53)",
"NDC11Code": "43598-0004-53",
"ProductNDC": "43598-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19901022",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050575",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "250; 62.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"Description": "AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of AUGMENTIN contains 0.63 mEq potassium."
},
{
"NDCCode": "43598-006-14",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (43598-006-14)",
"NDC11Code": "43598-0006-14",
"ProductNDC": "43598-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19901022",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050564",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "500; 125",
"StrengthUnit": "mg/1; 1/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"Description": "AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of AUGMENTIN contains 0.63 mEq potassium."
},
{
"NDCCode": "43598-006-78",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (43598-006-78)",
"NDC11Code": "43598-0006-78",
"ProductNDC": "43598-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augmentin",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19901022",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050564",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "500; 125",
"StrengthUnit": "mg/1; 1/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"Description": "AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of AUGMENTIN contains 0.63 mEq potassium."
},
{
"NDCCode": "43598-008-01",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (43598-008-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20) ",
"NDC11Code": "43598-0008-01",
"ProductNDC": "43598-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin 600 Mg",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215932",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220901",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegum (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "43598-008-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-008-10) ",
"NDC11Code": "43598-0008-10",
"ProductNDC": "43598-008",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-07-30",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-MAR-22"
},
{
"NDCCode": "43598-008-40",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (43598-008-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20) ",
"NDC11Code": "43598-0008-40",
"ProductNDC": "43598-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin 600 Mg",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215932",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220315",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegum (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "43598-008-97",
"PackageDescription": "64 BLISTER PACK in 1 CASE (43598-008-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20) ",
"NDC11Code": "43598-0008-97",
"ProductNDC": "43598-008",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-07-30",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "25-JUL-23"
},
{
"NDCCode": "43598-009-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-009-10) ",
"NDC11Code": "43598-0009-10",
"ProductNDC": "43598-009",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-07-30",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-MAR-22"
},
{
"NDCCode": "43598-009-25",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (43598-009-25) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-009-74) ",
"NDC11Code": "43598-0009-25",
"ProductNDC": "43598-009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin 1200 Mg",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215932",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220315",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegum (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "43598-009-37",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (43598-009-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-009-74) ",
"NDC11Code": "43598-0009-37",
"ProductNDC": "43598-009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin 1200 Mg",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215932",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220901",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegum (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "43598-010-01",
"PackageDescription": "1 PACKET in 1 CARTON (43598-010-01) / 1 POWDER, FOR SUSPENSION in 1 PACKET",
"NDC11Code": "43598-0010-01",
"ProductNDC": "43598-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Omeprazole And Sodium Bicarbonate",
"NonProprietaryName": "Omeprazole And Sodium Bicarbonate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20240715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217784",
"LabelerName": "Dr. Reddy's Laboratories 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": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240715",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week) . not intended for immediate relief of heartburn. This drug may take 1 to 4 days for full effect. ."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>43598-054-89</NDCCode>
<PackageDescription>1500 TABLET in 1 POUCH (43598-054-89) </PackageDescription>
<NDC11Code>43598-0054-89</NDC11Code>
<ProductNDC>43598-054</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20220110</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-JAN-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43598-008-89</NDCCode>
<PackageDescription>1280 TABLET, EXTENDED RELEASE in 1 CASE (43598-008-89) </PackageDescription>
<NDC11Code>43598-0008-89</NDC11Code>
<ProductNDC>43598-008</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-30</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-JUL-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43598-408-89</NDCCode>
<PackageDescription>1500 CAPSULE, DELAYED RELEASE in 1 POUCH (43598-408-89)</PackageDescription>
<NDC11Code>43598-0408-89</NDC11Code>
<ProductNDC>43598-408</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Omeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<StartMarketingDate>20150102</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43598-577-89</NDCCode>
<PackageDescription>1500 TABLET in 1 POUCH (43598-577-89) </PackageDescription>
<NDC11Code>43598-0577-89</NDC11Code>
<ProductNDC>43598-577</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20160725</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-01-16</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-JUL-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43598-086-58</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (43598-086-58) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>43598-0086-58</NDC11Code>
<ProductNDC>43598-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<ProprietaryNameSuffix>Doxycycline</ProprietaryNameSuffix>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218753</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline for injection and other antibacterial drugs, doxycycline for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated in infections caused by the following microorganisms: 1 Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, , 2 Q fever, rickettsial pox and tick fevers)., 3 Mycoplasma pneumoniae (PPLO, Eaton Agent). , 4 Agents of psittacosis and ornithosis., 5 Agents of lymphogranuloma venereum and granuloma inguinale., 6 The spirochetal agent of relapsing fever (Borrelia recurrentis).</IndicationAndUsage>
<Description>Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, USP, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate, USP is a broad spectrum antibiotic derived from oxytetracycline. It is meant for INTRAVENOUS use only after reconstitution. Doxycycline hyclate, USP is a yellow to light yellow powder which is chemically designated 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11- dioxo-2-naphthacenecarboxamide, monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. It has the following structural formula. (C22H24N2O8·HCl)2·C2H6O·H2O M.W.1025.89. Doxycycline hyclate, USP is soluble in water and chars at 201°C without melting. The base doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Each 100 mg vial contains: Doxycycline hyclate, USP equivalent to 100 mg doxycycline; ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3.</Description>
</NDC>
<NDC>
<NDCCode>43598-975-58</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (43598-975-58) / 100 mL in 1 VIAL (43598-975-11) </PackageDescription>
<NDC11Code>43598-0975-58</NDC11Code>
<ProductNDC>43598-975</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209307</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Inc</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride, USP is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride, USP has a molecular weight of 236.7 and the empirical formula is C13H16N2HCl and the structural formula is. Dexmedetomidine hydrochloride, USP is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride, USP equivalent to 4 mcg (0.004 mg) of dexmedetomidine and 9 mg sodium chloride in water and is ready to be used. The solution is preservative-free and contains no additives or chemical stabilizers.</Description>
</NDC>
<NDC>
<NDCCode>43598-976-58</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (43598-976-58) / 50 mL in 1 VIAL (43598-976-11) </PackageDescription>
<NDC11Code>43598-0976-58</NDC11Code>
<ProductNDC>43598-976</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209307</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Inc</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride, USP is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride, USP has a molecular weight of 236.7 and the empirical formula is C13H16N2HCl and the structural formula is. Dexmedetomidine hydrochloride, USP is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride, USP equivalent to 4 mcg (0.004 mg) of dexmedetomidine and 9 mg sodium chloride in water and is ready to be used. The solution is preservative-free and contains no additives or chemical stabilizers.</Description>
</NDC>
<NDC>
<NDCCode>43598-001-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-10) </PackageDescription>
<NDC11Code>43598-0001-10</NDC11Code>
<ProductNDC>43598-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078421</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43598-001-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-30) </PackageDescription>
<NDC11Code>43598-0001-30</NDC11Code>
<ProductNDC>43598-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078421</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43598-001-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-90) </PackageDescription>
<NDC11Code>43598-0001-90</NDC11Code>
<ProductNDC>43598-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078421</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43598-002-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-05) </PackageDescription>
<NDC11Code>43598-0002-05</NDC11Code>
<ProductNDC>43598-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078421</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43598-002-10</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-10) </PackageDescription>
<NDC11Code>43598-0002-10</NDC11Code>
<ProductNDC>43598-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078421</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43598-002-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-30) </PackageDescription>
<NDC11Code>43598-0002-30</NDC11Code>
<ProductNDC>43598-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078421</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43598-002-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-90) </PackageDescription>
<NDC11Code>43598-0002-90</NDC11Code>
<ProductNDC>43598-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078421</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43598-003-51</NDCCode>
<PackageDescription>75 mL in 1 BOTTLE (43598-003-51)</PackageDescription>
<NDC11Code>43598-0003-51</NDC11Code>
<ProductNDC>43598-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augmentin Es-600</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050755</ApplicationNumber>
<LabelerName>Dr Reddys Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.</IndicationAndUsage>
<Description>AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as.</Description>
</NDC>
<NDC>
<NDCCode>43598-003-54</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (43598-003-54)</PackageDescription>
<NDC11Code>43598-0003-54</NDC11Code>
<ProductNDC>43598-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augmentin Es-600</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050755</ApplicationNumber>
<LabelerName>Dr Reddys Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.</IndicationAndUsage>
<Description>AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as.</Description>
</NDC>
<NDC>
<NDCCode>43598-003-69</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE (43598-003-69)</PackageDescription>
<NDC11Code>43598-0003-69</NDC11Code>
<ProductNDC>43598-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augmentin Es-600</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050755</ApplicationNumber>
<LabelerName>Dr Reddys Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>AUGMENTIN ES-600 Powder for Oral Suspension is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors: 1 antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: age ≤ 2 yearsdaycare attendance.</IndicationAndUsage>
<Description>AUGMENTIN ES-600 Powder for Oral Suspension is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R ,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as.</Description>
</NDC>
<NDC>
<NDCCode>43598-004-51</NDCCode>
<PackageDescription>75 mL in 1 BOTTLE (43598-004-51)</PackageDescription>
<NDC11Code>43598-0004-51</NDC11Code>
<ProductNDC>43598-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augmentin</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19901022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050575</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>250; 62.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<Description>AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of AUGMENTIN contains 0.63 mEq potassium.</Description>
</NDC>
<NDC>
<NDCCode>43598-004-52</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (43598-004-52)</PackageDescription>
<NDC11Code>43598-0004-52</NDC11Code>
<ProductNDC>43598-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augmentin</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19901022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050575</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>250; 62.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<Description>AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of AUGMENTIN contains 0.63 mEq potassium.</Description>
</NDC>
<NDC>
<NDCCode>43598-004-53</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE (43598-004-53)</PackageDescription>
<NDC11Code>43598-0004-53</NDC11Code>
<ProductNDC>43598-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augmentin</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19901022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050575</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>250; 62.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<Description>AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of AUGMENTIN contains 0.63 mEq potassium.</Description>
</NDC>
<NDC>
<NDCCode>43598-006-14</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (43598-006-14)</PackageDescription>
<NDC11Code>43598-0006-14</NDC11Code>
<ProductNDC>43598-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augmentin</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19901022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050564</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>500; 125</StrengthNumber>
<StrengthUnit>mg/1; 1/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<Description>AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of AUGMENTIN contains 0.63 mEq potassium.</Description>
</NDC>
<NDC>
<NDCCode>43598-006-78</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (43598-006-78)</PackageDescription>
<NDC11Code>43598-0006-78</NDC11Code>
<ProductNDC>43598-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augmentin</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19901022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050564</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>500; 125</StrengthNumber>
<StrengthUnit>mg/1; 1/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<Description>AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of AUGMENTIN contains 0.63 mEq potassium.</Description>
</NDC>
<NDC>
<NDCCode>43598-008-01</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (43598-008-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20) </PackageDescription>
<NDC11Code>43598-0008-01</NDC11Code>
<ProductNDC>43598-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guaifenesin 600 Mg</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215932</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegum (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-008-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-008-10) </PackageDescription>
<NDC11Code>43598-0008-10</NDC11Code>
<ProductNDC>43598-008</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-30</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-MAR-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43598-008-40</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (43598-008-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20) </PackageDescription>
<NDC11Code>43598-0008-40</NDC11Code>
<ProductNDC>43598-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guaifenesin 600 Mg</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215932</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegum (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-008-97</NDCCode>
<PackageDescription>64 BLISTER PACK in 1 CASE (43598-008-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20) </PackageDescription>
<NDC11Code>43598-0008-97</NDC11Code>
<ProductNDC>43598-008</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-30</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-JUL-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43598-009-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-009-10) </PackageDescription>
<NDC11Code>43598-0009-10</NDC11Code>
<ProductNDC>43598-009</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-30</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-MAR-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43598-009-25</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (43598-009-25) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-009-74) </PackageDescription>
<NDC11Code>43598-0009-25</NDC11Code>
<ProductNDC>43598-009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guaifenesin 1200 Mg</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215932</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegum (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-009-37</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (43598-009-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-009-74) </PackageDescription>
<NDC11Code>43598-0009-37</NDC11Code>
<ProductNDC>43598-009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guaifenesin 1200 Mg</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215932</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegum (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-010-01</NDCCode>
<PackageDescription>1 PACKET in 1 CARTON (43598-010-01) / 1 POWDER, FOR SUSPENSION in 1 PACKET</PackageDescription>
<NDC11Code>43598-0010-01</NDC11Code>
<ProductNDC>43598-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Omeprazole And Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Omeprazole And Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217784</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories 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>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week) . not intended for immediate relief of heartburn. This drug may take 1 to 4 days for full effect. .</IndicationAndUsage>
</NDC>
</NDCList>