{
"NDC": [
{
"NDCCode": "65162-617-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (65162-617-50) ",
"NDC11Code": "65162-0617-50",
"ProductNDC": "65162-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091217",
"EndMarketingDate": "20240106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090485",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "325; 37.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20091217",
"EndMarketingDatePackage": "20240106",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "65162-617-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (65162-617-03) ",
"NDC11Code": "65162-0617-03",
"ProductNDC": "65162-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091217",
"EndMarketingDate": "20240106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090485",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "325; 37.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20091217",
"EndMarketingDatePackage": "20240106",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "65162-617-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (65162-617-10) ",
"NDC11Code": "65162-0617-10",
"ProductNDC": "65162-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091217",
"EndMarketingDate": "20240106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090485",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "325; 37.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20091217",
"EndMarketingDatePackage": "20240106",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "65162-617-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (65162-617-11) ",
"NDC11Code": "65162-0617-11",
"ProductNDC": "65162-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091217",
"EndMarketingDate": "20240106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090485",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "325; 37.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20091217",
"EndMarketingDatePackage": "20240106",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "65162-617-60",
"PackageDescription": "10 TABLET in 1 BLISTER PACK (65162-617-60)",
"NDC11Code": "65162-0617-60",
"ProductNDC": "65162-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090485",
"LabelerName": "Amneal Pharmaceuticals",
"SubstanceName": "ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "325; 37.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-03-31"
},
{
"NDCCode": "10967-617-27",
"PackageDescription": "50 mL in 1 CONTAINER (10967-617-27) ",
"NDC11Code": "10967-0617-27",
"ProductNDC": "10967-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mitchum Advanced Control Solid",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly Liquid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Revlon Consumer Products Corp",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "Reduces underarm wetness."
},
{
"NDCCode": "16252-617-50",
"PackageDescription": "1 BOTTLE in 1 CARTON (16252-617-50) > 500 TABLET in 1 BOTTLE",
"NDC11Code": "16252-0617-50",
"ProductNDC": "16252-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160502",
"EndMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079167",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160823",
"EndMarketingDatePackage": "20180930",
"SamplePackage": "N"
},
{
"NDCCode": "17139-617-40",
"PackageDescription": "50 g in 1 BOTTLE, PUMP (17139-617-40) ",
"NDC11Code": "17139-0617-40",
"ProductNDC": "17139-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estrogel",
"NonProprietaryName": "Estradiol",
"DosageFormName": "GEL, METERED",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021166",
"LabelerName": "ASCEND Therapeutics US, LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1.25g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040209",
"SamplePackage": "N",
"IndicationAndUsage": "EstroGel 0.06% is an estrogen indicated for: 1 Treatment of moderate to severe vasomotor symptoms due to menopause (1.1), 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause (1.2).",
"Description": "EstroGel (estradiol gel) contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless gel, which is odorless when dry. One pump depression of EstroGel delivers 1.25 g of gel containing 0.75 mg estradiol. Estradiol is a white crystalline powder, chemically described as estra‑1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol, triethanolamine and carbomer 974P) are pharmacologically inactive."
},
{
"NDCCode": "17139-617-43",
"PackageDescription": "3 BOTTLE, PUMP in 1 CARTON (17139-617-43) > 50 g in 1 BOTTLE, PUMP",
"NDC11Code": "17139-0617-43",
"ProductNDC": "17139-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estrogel",
"NonProprietaryName": "Estradiol",
"DosageFormName": "GEL, METERED",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20040209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021166",
"LabelerName": "ASCEND Therapeutics US, LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1.25g",
"Pharm_Classes": "Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-09-04"
},
{
"NDCCode": "30142-617-71",
"PackageDescription": "1 BOTTLE in 1 CARTON (30142-617-71) > 50 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "30142-0617-71",
"ProductNDC": "30142-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970116",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074661",
"LabelerName": "Kroger Company",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970116",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "43547-617-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (43547-617-50) ",
"NDC11Code": "43547-0617-50",
"ProductNDC": "43547-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217368",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220705",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate tablets are a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3‑ [(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate, USP, has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets are available as 5 and 10 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Crospovidone, Dicalcium Phosphate Anhydrous, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Pregelatinized Starch. The coating materials for all strengths contain Macrogol/PEG, Polyvinyl Alcohol-part hydrolyzed, Talc, Titanium Dioxide. The 5 mg tablets also contain Red Iron Oxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "47682-617-33",
"PackageDescription": "50 PACKET in 1 BOX (47682-617-33) / 2 TABLET, FILM COATED in 1 PACKET",
"NDC11Code": "47682-0617-33",
"ProductNDC": "47682-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi-first Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200720",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Unifirst First Aid Corporation",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200720",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves: 1 headache, 2 toothache, 3 pain and fever of colds, 4 muscle pain, 5 menstrual pain, 6 minor pain of arthritis."
},
{
"NDCCode": "47682-617-50",
"PackageDescription": "25 PACKET in 1 BOX (47682-617-50) / 2 TABLET, FILM COATED in 1 PACKET",
"NDC11Code": "47682-0617-50",
"ProductNDC": "47682-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi-first Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200720",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Unifirst First Aid Corporation",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200720",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves: 1 headache, 2 toothache, 3 pain and fever of colds, 4 muscle pain, 5 menstrual pain, 6 minor pain of arthritis."
},
{
"NDCCode": "49483-617-50",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (49483-617-50) ",
"NDC11Code": "49483-0617-50",
"ProductNDC": "49483-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091416",
"LabelerName": "TIME CAP LABORATORIES",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2018-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160706",
"SamplePackage": "N",
"IndicationAndUsage": "CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH INDIVIDUAL PATIENT TREATMENT GOALS (SEE WARNINGS: GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). NAPROXEN TABLETS ARE INDICATED. FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS. FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS. FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS. FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF JUVENILE ARTHRITIS. NAPROXEN TABLETS ARE ALSO INDICATED. FOR RELIEF OF THE SIGNS AND SYMPTOMS OF TENDONITIS. FOR RELIEF OF THE SIGNS AND SYMPTOMS OF BURSITIS. FOR RELIEF OF THE SIGNS AND SYMPTOMS OF ACUTE GOUT. FOR THE MANAGEMENT OF PAIN. FOR THE MANAGEMENT OF PRIMARY DYSMENORRHEA."
},
{
"NDCCode": "51293-617-67",
"PackageDescription": "50 CAPSULE in 1 BOTTLE, GLASS (51293-617-67)",
"NDC11Code": "51293-0617-67",
"ProductNDC": "51293-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isometheptene Mucate/dichloralphenazone/acetaminophen",
"NonProprietaryName": "Isometheptene Mucate, Dichloralphenazone, And Acetaminophen",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110215",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ECI Pharmaceuticals LLC",
"SubstanceName": "ISOMETHEPTENE MUCATE; DICHLORALPHENAZONE; ACETAMINOPHEN",
"StrengthNumber": "65; 100; 325",
"StrengthUnit": "mg/1; mg/1; mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-04-16",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "59779-617-50",
"PackageDescription": "265 mL in 1 CANISTER (59779-617-50) ",
"NDC11Code": "59779-0617-50",
"ProductNDC": "59779-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Pharmacy Instant Hand Sanitizing Wipes",
"NonProprietaryName": "Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".659",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150301",
"SamplePackage": "N"
},
{
"NDCCode": "63323-617-50",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-617-50) / 50 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "63323-0617-50",
"ProductNDC": "63323-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Milrinone Lactate",
"NonProprietaryName": "Milrinone Lactate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20020801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075936",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "MILRINONE LACTATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-04-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020801",
"SamplePackage": "N",
"IndicationAndUsage": "Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.",
"Description": "Milrinone lactate injection is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-dihydro-2-methyl-6-oxo-[3,4'-bipyridine]-5-carbonitrile lactate and has the following structure:. C12H9N3O M.W. 211.2. Milrinone is an off-white to tan crystalline compound. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone lactate injection is available as sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, single-dose vials of 10, 20, and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous, USP, in Water for Injection, USP. The pH is adjusted to between 3.2 and 4.0 with lactic acid or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously."
},
{
"NDCCode": "69625-617-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (69625-617-01) / 50 mL in 1 BOTTLE",
"NDC11Code": "69625-0617-01",
"ProductNDC": "69625-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vichy Laboratoires Normaderm Acne Control Daily Moisturizer",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Cosmetique Active Production",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260615",
"SamplePackage": "N",
"IndicationAndUsage": "for the treatment of acne. clears acne blemishes and allows skin to heal. helps prevent new acne blemishes."
},
{
"NDCCode": "71901-617-01",
"PackageDescription": "50 kg in 1 DRUM (71901-617-01) ",
"NDC11Code": "71901-0617-01",
"ProductNDC": "71901-617",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pridinol Mesilate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250823",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Emnar Pharma Private Limited",
"SubstanceName": "PRIDINOL MESILATE",
"StrengthNumber": "50",
"StrengthUnit": "kg/50kg",
"Status": "Unfinished",
"LastUpdate": "2025-08-26",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "23-AUG-25"
},
{
"NDCCode": "71919-617-09",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-617-09) ",
"NDC11Code": "71919-0617-09",
"ProductNDC": "71919-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scutellaria Lateriflora",
"NonProprietaryName": "Scutellaria Lateriflora",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SCUTELLARIA LATERIFLORA",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. SCUTELLARIA Muscle twitching."
},
{
"NDCCode": "82046-617-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (82046-617-01) / 50 mL in 1 BOTTLE",
"NDC11Code": "82046-0617-01",
"ProductNDC": "82046-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vichy Laboratoires Normaderm Acne Control Daily Moisturizer",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "L�Oreal USA Products Inc",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260615",
"SamplePackage": "N",
"IndicationAndUsage": "for the treatment of acne. clears acne blemishes and allows skin to heal. helps prevent new acne blemishes."
},
{
"NDCCode": "83566-617-01",
"PackageDescription": "50 g in 1 JAR (83566-617-01) ",
"NDC11Code": "83566-0617-01",
"ProductNDC": "83566-617",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acolye Lidocaine Cream Topical Analgesia Cream",
"NonProprietaryName": "Lidocaine,menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260731",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Guangdong Aimu Biological Technology Co., Ltd",
"SubstanceName": "LIDOCAINE; MENTHOL",
"StrengthNumber": "4; 1",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. For the temporary relief of itching associated with fever blisters and cold sores."
},
{
"NDCCode": "65162-006-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (65162-006-50) ",
"NDC11Code": "65162-0006-50",
"ProductNDC": "65162-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100621",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078477",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100621",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) .",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "65162-007-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (65162-007-50) ",
"NDC11Code": "65162-0007-50",
"ProductNDC": "65162-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100621",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078477",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100621",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) .",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "65162-008-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (65162-008-50) ",
"NDC11Code": "65162-0008-50",
"ProductNDC": "65162-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100621",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078477",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100621",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) .",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "65162-015-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (65162-015-50) ",
"NDC11Code": "65162-0015-50",
"ProductNDC": "65162-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078826",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100623",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam tablets, in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. C15H10Cl2N2O2 M.W. 321.16. It is a nearly white powder almost insoluble in water. Each lorazepam tablet, USP to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "65162-017-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (65162-017-50) ",
"NDC11Code": "65162-0017-50",
"ProductNDC": "65162-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078826",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100623",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam tablets, in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. C15H10Cl2N2O2 M.W. 321.16. It is a nearly white powder almost insoluble in water. Each lorazepam tablet, USP to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "65162-018-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (65162-018-50) ",
"NDC11Code": "65162-0018-50",
"ProductNDC": "65162-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078826",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100623",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam tablets, in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. C15H10Cl2N2O2 M.W. 321.16. It is a nearly white powder almost insoluble in water. Each lorazepam tablet, USP to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "65162-019-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65162-019-50) ",
"NDC11Code": "65162-0019-50",
"ProductNDC": "65162-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram Oxalate",
"NonProprietaryName": "Escitalopram Oxalate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205619",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170517",
"SamplePackage": "N",
"IndicationAndUsage": "Escitalopram tablets are indicated for the treatment of: 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. .",
"Description": "Escitalopram tablet contains escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate and insoluble in heptane. Escitalopram tablets, USP are film-coated, round tablets containing 6.387 mg, 12.774 mg, 25.549 mg escitalopram oxalate, USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: butylated hydroxyanisole, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
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"Description": "Escitalopram tablet contains escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate and insoluble in heptane. Escitalopram tablets, USP are film-coated, round tablets containing 6.387 mg, 12.774 mg, 25.549 mg escitalopram oxalate, USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: butylated hydroxyanisole, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide and titanium dioxide. FDA approved dissolution test specifications differ from USP."
}
]
}
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<NDCCode>65162-617-10</NDCCode>
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<ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName>
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<Description>Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2.</Description>
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<NDCCode>65162-617-11</NDCCode>
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<DEASchedule>CIV</DEASchedule>
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<LastUpdate>2024-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20091217</StartMarketingDatePackage>
<EndMarketingDatePackage>20240106</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol hydrochloride and acetaminophen tablets, USP combines two analgesics, tramadol hydrochloride, USP and opioid agonist, and acetaminophen, USP. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline, and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg of tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablet are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized corn starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meets USP Dissolution Test 2.</Description>
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<Status>Deprecated</Status>
<LastUpdate>2014-03-31</LastUpdate>
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<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Reduces underarm wetness.</IndicationAndUsage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160502</StartMarketingDate>
<EndMarketingDate>20181031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079167</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2018-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160823</StartMarketingDatePackage>
<EndMarketingDatePackage>20180930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>50 g in 1 BOTTLE, PUMP (17139-617-40) </PackageDescription>
<NDC11Code>17139-0617-40</NDC11Code>
<ProductNDC>17139-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estrogel</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>GEL, METERED</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040209</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021166</ApplicationNumber>
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<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1.25g</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EstroGel 0.06% is an estrogen indicated for: 1 Treatment of moderate to severe vasomotor symptoms due to menopause (1.1), 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause (1.2).</IndicationAndUsage>
<Description>EstroGel (estradiol gel) contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless gel, which is odorless when dry. One pump depression of EstroGel delivers 1.25 g of gel containing 0.75 mg estradiol. Estradiol is a white crystalline powder, chemically described as estra‑1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol, triethanolamine and carbomer 974P) are pharmacologically inactive.</Description>
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<Status>Deprecated</Status>
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<RouteName>ORAL</RouteName>
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<EndMarketingDate>20230331</EndMarketingDate>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970116</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
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<NDC11Code>43547-0617-50</NDC11Code>
<ProductNDC>43547-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217368</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate tablets are a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3‑ [(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and its structure is. Bisoprolol fumarate, USP, has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets are available as 5 and 10 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Crospovidone, Dicalcium Phosphate Anhydrous, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Pregelatinized Starch. The coating materials for all strengths contain Macrogol/PEG, Polyvinyl Alcohol-part hydrolyzed, Talc, Titanium Dioxide. The 5 mg tablets also contain Red Iron Oxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>47682-617-33</NDCCode>
<PackageDescription>50 PACKET in 1 BOX (47682-617-33) / 2 TABLET, FILM COATED in 1 PACKET</PackageDescription>
<NDC11Code>47682-0617-33</NDC11Code>
<ProductNDC>47682-617</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi-first Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200720</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves: 1 headache, 2 toothache, 3 pain and fever of colds, 4 muscle pain, 5 menstrual pain, 6 minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47682-617-50</NDCCode>
<PackageDescription>25 PACKET in 1 BOX (47682-617-50) / 2 TABLET, FILM COATED in 1 PACKET</PackageDescription>
<NDC11Code>47682-0617-50</NDC11Code>
<ProductNDC>47682-617</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi-first Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200720</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves: 1 headache, 2 toothache, 3 pain and fever of colds, 4 muscle pain, 5 menstrual pain, 6 minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49483-617-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (49483-617-50) </PackageDescription>
<NDC11Code>49483-0617-50</NDC11Code>
<ProductNDC>49483-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160706</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091416</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH INDIVIDUAL PATIENT TREATMENT GOALS (SEE WARNINGS: GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). NAPROXEN TABLETS ARE INDICATED. FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS. FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS. FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS. FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF JUVENILE ARTHRITIS. NAPROXEN TABLETS ARE ALSO INDICATED. FOR RELIEF OF THE SIGNS AND SYMPTOMS OF TENDONITIS. FOR RELIEF OF THE SIGNS AND SYMPTOMS OF BURSITIS. FOR RELIEF OF THE SIGNS AND SYMPTOMS OF ACUTE GOUT. FOR THE MANAGEMENT OF PAIN. FOR THE MANAGEMENT OF PRIMARY DYSMENORRHEA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51293-617-67</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE, GLASS (51293-617-67)</PackageDescription>
<NDC11Code>51293-0617-67</NDC11Code>
<ProductNDC>51293-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isometheptene Mucate/dichloralphenazone/acetaminophen</ProprietaryName>
<NonProprietaryName>Isometheptene Mucate, Dichloralphenazone, And Acetaminophen</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ECI Pharmaceuticals LLC</LabelerName>
<SubstanceName>ISOMETHEPTENE MUCATE; DICHLORALPHENAZONE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>65; 100; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-04-16</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59779-617-50</NDCCode>
<PackageDescription>265 mL in 1 CANISTER (59779-617-50) </PackageDescription>
<NDC11Code>59779-0617-50</NDC11Code>
<ProductNDC>59779-617</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Pharmacy Instant Hand Sanitizing Wipes</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.659</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63323-617-50</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (63323-617-50) / 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>63323-0617-50</NDC11Code>
<ProductNDC>63323-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Milrinone Lactate</ProprietaryName>
<NonProprietaryName>Milrinone Lactate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20020801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075936</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>MILRINONE LACTATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.</IndicationAndUsage>
<Description>Milrinone lactate injection is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-dihydro-2-methyl-6-oxo-[3,4'-bipyridine]-5-carbonitrile lactate and has the following structure:. C12H9N3O M.W. 211.2. Milrinone is an off-white to tan crystalline compound. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone lactate injection is available as sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, single-dose vials of 10, 20, and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous, USP, in Water for Injection, USP. The pH is adjusted to between 3.2 and 4.0 with lactic acid or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously.</Description>
</NDC>
<NDC>
<NDCCode>69625-617-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69625-617-01) / 50 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69625-0617-01</NDC11Code>
<ProductNDC>69625-617</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vichy Laboratoires Normaderm Acne Control Daily Moisturizer</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Cosmetique Active Production</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the treatment of acne. clears acne blemishes and allows skin to heal. helps prevent new acne blemishes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71901-617-01</NDCCode>
<PackageDescription>50 kg in 1 DRUM (71901-617-01) </PackageDescription>
<NDC11Code>71901-0617-01</NDC11Code>
<ProductNDC>71901-617</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pridinol Mesilate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250823</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Emnar Pharma Private Limited</LabelerName>
<SubstanceName>PRIDINOL MESILATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>kg/50kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-08-26</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-AUG-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71919-617-09</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (71919-617-09) </PackageDescription>
<NDC11Code>71919-0617-09</NDC11Code>
<ProductNDC>71919-617</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scutellaria Lateriflora</ProprietaryName>
<NonProprietaryName>Scutellaria Lateriflora</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SCUTELLARIA LATERIFLORA</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. SCUTELLARIA Muscle twitching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82046-617-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (82046-617-01) / 50 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>82046-0617-01</NDC11Code>
<ProductNDC>82046-617</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vichy Laboratoires Normaderm Acne Control Daily Moisturizer</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>L�Oreal USA Products Inc</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the treatment of acne. clears acne blemishes and allows skin to heal. helps prevent new acne blemishes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83566-617-01</NDCCode>
<PackageDescription>50 g in 1 JAR (83566-617-01) </PackageDescription>
<NDC11Code>83566-0617-01</NDC11Code>
<ProductNDC>83566-617</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acolye Lidocaine Cream Topical Analgesia Cream</ProprietaryName>
<NonProprietaryName>Lidocaine,menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Guangdong Aimu Biological Technology Co., Ltd</LabelerName>
<SubstanceName>LIDOCAINE; MENTHOL</SubstanceName>
<StrengthNumber>4; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. For the temporary relief of itching associated with fever blisters and cold sores.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65162-006-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (65162-006-50) </PackageDescription>
<NDC11Code>65162-0006-50</NDC11Code>
<ProductNDC>65162-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100621</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078477</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) .</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>65162-007-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (65162-007-50) </PackageDescription>
<NDC11Code>65162-0007-50</NDC11Code>
<ProductNDC>65162-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100621</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078477</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) .</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>65162-008-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (65162-008-50) </PackageDescription>
<NDC11Code>65162-0008-50</NDC11Code>
<ProductNDC>65162-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100621</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078477</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) .</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S, and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>65162-015-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (65162-015-50) </PackageDescription>
<NDC11Code>65162-0015-50</NDC11Code>
<ProductNDC>65162-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078826</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam tablets, in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. C15H10Cl2N2O2 M.W. 321.16. It is a nearly white powder almost insoluble in water. Each lorazepam tablet, USP to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>65162-017-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (65162-017-50) </PackageDescription>
<NDC11Code>65162-0017-50</NDC11Code>
<ProductNDC>65162-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078826</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam tablets, in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. C15H10Cl2N2O2 M.W. 321.16. It is a nearly white powder almost insoluble in water. Each lorazepam tablet, USP to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>65162-018-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (65162-018-50) </PackageDescription>
<NDC11Code>65162-0018-50</NDC11Code>
<ProductNDC>65162-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078826</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam tablets, in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. C15H10Cl2N2O2 M.W. 321.16. It is a nearly white powder almost insoluble in water. Each lorazepam tablet, USP to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>65162-019-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65162-019-50) </PackageDescription>
<NDC11Code>65162-0019-50</NDC11Code>
<ProductNDC>65162-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram Oxalate</ProprietaryName>
<NonProprietaryName>Escitalopram Oxalate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205619</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram tablets are indicated for the treatment of: 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. .</IndicationAndUsage>
<Description>Escitalopram tablet contains escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate and insoluble in heptane. Escitalopram tablets, USP are film-coated, round tablets containing 6.387 mg, 12.774 mg, 25.549 mg escitalopram oxalate, USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: butylated hydroxyanisole, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>65162-020-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65162-020-50) </PackageDescription>
<NDC11Code>65162-0020-50</NDC11Code>
<ProductNDC>65162-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram Oxalate</ProprietaryName>
<NonProprietaryName>Escitalopram Oxalate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205619</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram tablets are indicated for the treatment of: 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. .</IndicationAndUsage>
<Description>Escitalopram tablet contains escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate and insoluble in heptane. Escitalopram tablets, USP are film-coated, round tablets containing 6.387 mg, 12.774 mg, 25.549 mg escitalopram oxalate, USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: butylated hydroxyanisole, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
</NDCList>