{
"NDC": [
{
"NDCCode": "54868-4278-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (54868-4278-0) > 15 mL in 1 BOTTLE",
"NDC11Code": "54868-4278-00",
"ProductNDC": "54868-4278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lotemax",
"NonProprietaryName": "Loteprednol Etabonate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20021017",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020583",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "LOTEPREDNOL ETABONATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "LOTEMAX is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. LOTEMAX is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with LOTEMAX experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with LOTEMAX and 6% with prednisolone acetate 1%. LOTEMAX should not be used in patients who require a more potent corticosteroid for this indication. LOTEMAX is also indicated for the treatment of post-operative inflammation following ocular surgery.",
"Description": "LOTEMAX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17 β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 5 mg (0.5%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.5-5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%."
},
{
"NDCCode": "54868-4278-1",
"PackageDescription": "1 BOTTLE in 1 CARTON (54868-4278-1) > 5 mL in 1 BOTTLE",
"NDC11Code": "54868-4278-01",
"ProductNDC": "54868-4278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lotemax",
"NonProprietaryName": "Loteprednol Etabonate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20021017",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020583",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "LOTEPREDNOL ETABONATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "LOTEMAX is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. LOTEMAX is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with LOTEMAX experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with LOTEMAX and 6% with prednisolone acetate 1%. LOTEMAX should not be used in patients who require a more potent corticosteroid for this indication. LOTEMAX is also indicated for the treatment of post-operative inflammation following ocular surgery.",
"Description": "LOTEMAX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17 β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 5 mg (0.5%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.5-5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%."
},
{
"NDCCode": "0363-4278-45",
"PackageDescription": "1 KIT in 1 PACKAGE (0363-4278-45) * 177 mL in 1 BOTTLE, PLASTIC (0363-9042-45) * 177 mL in 1 BOTTLE, PLASTIC (0363-8078-45) ",
"NDC11Code": "00363-4278-45",
"ProductNDC": "0363-4278",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu",
"ProprietaryNameSuffix": "Daytime Nighttime Severe",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Triprolidine Hcl",
"DosageFormName": "KIT",
"StartMarketingDate": "20231021",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Walgreen Company",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231021",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms:sore throatnasal congestionstuffy noseminor aches and painssneezing (Nighttime only)headache coughrunny nose (Nighttime only)itching of the nose or throat (Nighttime only)itchy, watery eyes due to hay fever (Nighttime only)sinus congestion and pressure. temporarily reduces fever. controls cough to help you get to sleep . helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)."
},
{
"NDCCode": "0409-4278-01",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4278-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4278-16) ",
"NDC11Code": "00409-4278-01",
"ProductNDC": "0409-4278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; INTRAVENOUS",
"StartMarketingDate": "20050630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088328",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050630",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "Lidocaine Hydrochloride Injection, USP contains lidocaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Lidocaine Hydrochloride Injection is by injection, for infiltration, nerve block, epidural and caudal use. Multiple‑dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Lidocaine hydrochloride is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), monohydrochloride monohydrate and has the molecular weight is of 288.8 g/mol. Lidocaine hydrochloride molecular formula is C14H22N2OHClH2O, and has the following structural formula. Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, isotonic, clear solution containing lidocaine hydrochloride and sodium chloride in water for injection for parenteral administration in various concentrations with characteristics as follows. Multiple-dose vials contain 0.1% of methylparaben added as an antiseptic preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0) [See How Supplied/Storage and Handling (16)] for various sizes and strengths. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration."
},
{
"NDCCode": "0498-4278-01",
"PackageDescription": "1 KIT in 1 KIT (0498-4278-01) * .4 mL in 1 POUCH * .9 g in 1 PACKET (0498-0730-01) * .9 g in 1 PACKET * 1.4 mL in 1 PACKET * 2 TABLET in 1 PACKET (0498-2001-01) * 30 mL in 1 BOTTLE (0498-0100-01) ",
"NDC11Code": "00498-4278-01",
"ProductNDC": "0498-4278",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4278 First Aid Kit",
"NonProprietaryName": "4278 First Aid Kit",
"DosageFormName": "KIT",
"RouteName": "OPHTHALMIC; ORAL; TOPICAL",
"StartMarketingDate": "20181018",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Honeywell Safety Products USA, INC",
"Status": "Deprecated",
"LastUpdate": "2024-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181018",
"SamplePackage": "N"
},
{
"NDCCode": "61474-4278-1",
"PackageDescription": "2 BAG in 1 CARTON (61474-4278-1) > 8500 CAPSULE, LIQUID FILLED in 1 BAG",
"NDC11Code": "61474-4278-01",
"ProductNDC": "61474-4278",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"StartMarketingDate": "20170822",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Ontario Limited",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "62670-4278-0",
"PackageDescription": "29 mL in 1 BOTTLE (62670-4278-0)",
"NDC11Code": "62670-4278-00",
"ProductNDC": "62670-4278",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Cranapple Crisp",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120321",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2014-04-03"
},
{
"NDCCode": "62742-4278-2",
"PackageDescription": "1 TUBE in 1 CARTON (62742-4278-2) / 57 g in 1 TUBE (62742-4278-1) ",
"NDC11Code": "62742-4278-02",
"ProductNDC": "62742-4278",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Advanced Pain Relief Cream With 5 % Natural Menthol",
"NonProprietaryName": "Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260225",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Allure Labs",
"SubstanceName": "MENTHOL",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260225",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For the temporary relief of minor aches and pains of muscles and joints associated with. simple backache. arthritis. strains. bruises. sprains."
},
{
"NDCCode": "63629-4278-1",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-1) ",
"NDC11Code": "63629-4278-01",
"ProductNDC": "63629-4278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20111001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079163",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211222",
"SamplePackage": "N",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed release tablets, USP are for oral administration. Divalproex sodium delayed release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "63629-4278-2",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-2) ",
"NDC11Code": "63629-4278-02",
"ProductNDC": "63629-4278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20111001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079163",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121119",
"SamplePackage": "N",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed release tablets, USP are for oral administration. Divalproex sodium delayed release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "63629-4278-3",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-3) ",
"NDC11Code": "63629-4278-03",
"ProductNDC": "63629-4278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20111001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079163",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141110",
"SamplePackage": "N",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed release tablets, USP are for oral administration. Divalproex sodium delayed release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "63629-4278-4",
"PackageDescription": "180 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-4) ",
"NDC11Code": "63629-4278-04",
"ProductNDC": "63629-4278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20111001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079163",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed release tablets, USP are for oral administration. Divalproex sodium delayed release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "63629-4278-5",
"PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-5) ",
"NDC11Code": "63629-4278-05",
"ProductNDC": "63629-4278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20111001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079163",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180917",
"SamplePackage": "N",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed release tablets, USP are for oral administration. Divalproex sodium delayed release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "68071-4278-5",
"PackageDescription": "15 g in 1 BOX (68071-4278-5) ",
"NDC11Code": "68071-4278-05",
"ProductNDC": "68071-4278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Valerate",
"NonProprietaryName": "Betamethasone Valerate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19880106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072041",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "BETAMETHASONE VALERATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180208",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Betamethasone Valerate Cream USP, 0.1% contains betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is. Each gram of Betamethasone Valerate Cream USP, 0.1% contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of ceteareth-15, cetyl alcohol, mineral oil, polyethylene glycol 1000, propylene glycol, purified water, stearyl alcohol, white petrolatum, phosphoric acid and sodium hydroxide (for pH adjustment); chlorocresol is present as a preservative."
},
{
"NDCCode": "70518-4278-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (70518-4278-0) / 100 mL in 1 BOTTLE",
"NDC11Code": "70518-4278-00",
"ProductNDC": "70518-4278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Viscous",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20250205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088802",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250205",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.",
"Description": "Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution, USP) contains a local anesthetic agent and is administered topically. Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution, USP) contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)- N-(2,6-dimethylphenyl)-,monohydrochloride, monohydrate and has the following structural formula:. The molecular formula of lidocaine is C 14H 22N 2O HCl H 2O. The molecular weight is 288.81. Composition of Solution:. Each mL contains 20 mg (2%) of lidocaine hydrochloride, USP and the following inactive ingredients: carboxymethylcellulose sodium, flavoring, methylparaben, propylparaben, purified water and saccharin sodium."
},
{
"NDCCode": "54868-0010-0",
"PackageDescription": ".296 mL in 1 BOTTLE, GLASS (54868-0010-0)",
"NDC11Code": "54868-0010-00",
"ProductNDC": "54868-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Citrate Of Magnesium",
"NonProprietaryName": "Citrate Of Magnesium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20030129",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "MAGNESIUM CITRATE",
"StrengthNumber": "1.745",
"StrengthUnit": "g/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54868-0016-0",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (54868-0016-0) > 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "54868-0016-00",
"ProductNDC": "54868-0016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dulcolax",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100519",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours."
},
{
"NDCCode": "54868-0017-1",
"PackageDescription": "10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-1)",
"NDC11Code": "54868-0017-01",
"ProductNDC": "54868-0017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niaspan",
"NonProprietaryName": "Niacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020381",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "NIACIN",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.",
"Description": "NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide."
},
{
"NDCCode": "54868-0017-2",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-2)",
"NDC11Code": "54868-0017-02",
"ProductNDC": "54868-0017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niaspan",
"NonProprietaryName": "Niacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020381",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "NIACIN",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.",
"Description": "NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide."
},
{
"NDCCode": "54868-0017-5",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-5)",
"NDC11Code": "54868-0017-05",
"ProductNDC": "54868-0017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niaspan",
"NonProprietaryName": "Niacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020381",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "NIACIN",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.",
"Description": "NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide."
},
{
"NDCCode": "54868-0017-6",
"PackageDescription": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-6)",
"NDC11Code": "54868-0017-06",
"ProductNDC": "54868-0017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Niaspan",
"NonProprietaryName": "Niacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020381",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "NIACIN",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.",
"Description": "NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide."
},
{
"NDCCode": "54868-0018-1",
"PackageDescription": "40 TABLET in 1 BOTTLE (54868-0018-1)",
"NDC11Code": "54868-0018-01",
"ProductNDC": "54868-0018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin Ethylsuccinate",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061904",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
},
{
"NDCCode": "54868-0018-3",
"PackageDescription": "20 TABLET in 1 BOTTLE (54868-0018-3)",
"NDC11Code": "54868-0018-03",
"ProductNDC": "54868-0018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin Ethylsuccinate",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061904",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
},
{
"NDCCode": "54868-0018-4",
"PackageDescription": "30 TABLET in 1 BOTTLE (54868-0018-4)",
"NDC11Code": "54868-0018-04",
"ProductNDC": "54868-0018",
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"ProprietaryName": "Erythromycin Ethylsuccinate",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061904",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
},
{
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"ProductNdcExcludeFlag": "E",
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
},
{
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"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
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"ProductNdcExcludeFlag": "E",
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
},
{
"NDCCode": "54868-0018-7",
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"ProductNdcExcludeFlag": "E",
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
},
{
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"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
},
{
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},
{
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}
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<NDC>
<NDCCode>54868-4278-0</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (54868-4278-0) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>54868-4278-00</NDC11Code>
<ProductNDC>54868-4278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lotemax</ProprietaryName>
<NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20021017</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020583</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LOTEMAX is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. LOTEMAX is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with LOTEMAX experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with LOTEMAX and 6% with prednisolone acetate 1%. LOTEMAX should not be used in patients who require a more potent corticosteroid for this indication. LOTEMAX is also indicated for the treatment of post-operative inflammation following ocular surgery.</IndicationAndUsage>
<Description>LOTEMAX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17 β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 5 mg (0.5%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.5-5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.</Description>
</NDC>
<NDC>
<NDCCode>54868-4278-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (54868-4278-1) > 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>54868-4278-01</NDC11Code>
<ProductNDC>54868-4278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lotemax</ProprietaryName>
<NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20021017</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020583</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LOTEMAX is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. LOTEMAX is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with LOTEMAX experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with LOTEMAX and 6% with prednisolone acetate 1%. LOTEMAX should not be used in patients who require a more potent corticosteroid for this indication. LOTEMAX is also indicated for the treatment of post-operative inflammation following ocular surgery.</IndicationAndUsage>
<Description>LOTEMAX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. C24H31ClO7Mol. Wt. 466.96. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17 β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 5 mg (0.5%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.5-5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.</Description>
</NDC>
<NDC>
<NDCCode>0363-4278-45</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (0363-4278-45) * 177 mL in 1 BOTTLE, PLASTIC (0363-9042-45) * 177 mL in 1 BOTTLE, PLASTIC (0363-8078-45) </PackageDescription>
<NDC11Code>00363-4278-45</NDC11Code>
<ProductNDC>0363-4278</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu</ProprietaryName>
<ProprietaryNameSuffix>Daytime Nighttime Severe</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Triprolidine Hcl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231021</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms:sore throatnasal congestionstuffy noseminor aches and painssneezing (Nighttime only)headache coughrunny nose (Nighttime only)itching of the nose or throat (Nighttime only)itchy, watery eyes due to hay fever (Nighttime only)sinus congestion and pressure. temporarily reduces fever. controls cough to help you get to sleep . helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0409-4278-01</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4278-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4278-16) </PackageDescription>
<NDC11Code>00409-4278-01</NDC11Code>
<ProductNDC>0409-4278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION; INTRAVENOUS</RouteName>
<StartMarketingDate>20050630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088328</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Injection, USP contains lidocaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Lidocaine Hydrochloride Injection is by injection, for infiltration, nerve block, epidural and caudal use. Multiple‑dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Lidocaine hydrochloride is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), monohydrochloride monohydrate and has the molecular weight is of 288.8 g/mol. Lidocaine hydrochloride molecular formula is C14H22N2OHClH2O, and has the following structural formula. Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, isotonic, clear solution containing lidocaine hydrochloride and sodium chloride in water for injection for parenteral administration in various concentrations with characteristics as follows. Multiple-dose vials contain 0.1% of methylparaben added as an antiseptic preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0) [See How Supplied/Storage and Handling (16)] for various sizes and strengths. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.</Description>
</NDC>
<NDC>
<NDCCode>0498-4278-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0498-4278-01) * .4 mL in 1 POUCH * .9 g in 1 PACKET (0498-0730-01) * .9 g in 1 PACKET * 1.4 mL in 1 PACKET * 2 TABLET in 1 PACKET (0498-2001-01) * 30 mL in 1 BOTTLE (0498-0100-01) </PackageDescription>
<NDC11Code>00498-4278-01</NDC11Code>
<ProductNDC>0498-4278</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4278 First Aid Kit</ProprietaryName>
<NonProprietaryName>4278 First Aid Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>OPHTHALMIC; ORAL; TOPICAL</RouteName>
<StartMarketingDate>20181018</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Honeywell Safety Products USA, INC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61474-4278-1</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (61474-4278-1) > 8500 CAPSULE, LIQUID FILLED in 1 BAG</PackageDescription>
<NDC11Code>61474-4278-01</NDC11Code>
<ProductNDC>61474-4278</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<StartMarketingDate>20170822</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Ontario Limited</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62670-4278-0</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (62670-4278-0)</PackageDescription>
<NDC11Code>62670-4278-00</NDC11Code>
<ProductNDC>62670-4278</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Cranapple Crisp</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120321</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>62742-4278-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62742-4278-2) / 57 g in 1 TUBE (62742-4278-1) </PackageDescription>
<NDC11Code>62742-4278-02</NDC11Code>
<ProductNDC>62742-4278</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Advanced Pain Relief Cream With 5 % Natural Menthol</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260225</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Allure Labs</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For the temporary relief of minor aches and pains of muscles and joints associated with. simple backache. arthritis. strains. bruises. sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63629-4278-1</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-1) </PackageDescription>
<NDC11Code>63629-4278-01</NDC11Code>
<ProductNDC>63629-4278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079163</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed release tablets, USP are for oral administration. Divalproex sodium delayed release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>63629-4278-2</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-2) </PackageDescription>
<NDC11Code>63629-4278-02</NDC11Code>
<ProductNDC>63629-4278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079163</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed release tablets, USP are for oral administration. Divalproex sodium delayed release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>63629-4278-3</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-3) </PackageDescription>
<NDC11Code>63629-4278-03</NDC11Code>
<ProductNDC>63629-4278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079163</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed release tablets, USP are for oral administration. Divalproex sodium delayed release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>63629-4278-4</NDCCode>
<PackageDescription>180 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-4) </PackageDescription>
<NDC11Code>63629-4278-04</NDC11Code>
<ProductNDC>63629-4278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079163</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed release tablets, USP are for oral administration. Divalproex sodium delayed release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>63629-4278-5</NDCCode>
<PackageDescription>120 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-5) </PackageDescription>
<NDC11Code>63629-4278-05</NDC11Code>
<ProductNDC>63629-4278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079163</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed release tablets, USP are for oral administration. Divalproex sodium delayed release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>68071-4278-5</NDCCode>
<PackageDescription>15 g in 1 BOX (68071-4278-5) </PackageDescription>
<NDC11Code>68071-4278-05</NDC11Code>
<ProductNDC>68071-4278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Valerate</ProprietaryName>
<NonProprietaryName>Betamethasone Valerate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19880106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072041</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>BETAMETHASONE VALERATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone Valerate Cream USP, 0.1% contains betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is. Each gram of Betamethasone Valerate Cream USP, 0.1% contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of ceteareth-15, cetyl alcohol, mineral oil, polyethylene glycol 1000, propylene glycol, purified water, stearyl alcohol, white petrolatum, phosphoric acid and sodium hydroxide (for pH adjustment); chlorocresol is present as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>70518-4278-0</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70518-4278-0) / 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70518-4278-00</NDC11Code>
<ProductNDC>70518-4278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Viscous</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20250205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088802</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.</IndicationAndUsage>
<Description>Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution, USP) contains a local anesthetic agent and is administered topically. Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution, USP) contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)- N-(2,6-dimethylphenyl)-,monohydrochloride, monohydrate and has the following structural formula:. The molecular formula of lidocaine is C 14H 22N 2O HCl H 2O. The molecular weight is 288.81. Composition of Solution:. Each mL contains 20 mg (2%) of lidocaine hydrochloride, USP and the following inactive ingredients: carboxymethylcellulose sodium, flavoring, methylparaben, propylparaben, purified water and saccharin sodium.</Description>
</NDC>
<NDC>
<NDCCode>54868-0010-0</NDCCode>
<PackageDescription>.296 mL in 1 BOTTLE, GLASS (54868-0010-0)</PackageDescription>
<NDC11Code>54868-0010-00</NDC11Code>
<ProductNDC>54868-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Citrate Of Magnesium</ProprietaryName>
<NonProprietaryName>Citrate Of Magnesium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>MAGNESIUM CITRATE</SubstanceName>
<StrengthNumber>1.745</StrengthNumber>
<StrengthUnit>g/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-0016-0</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (54868-0016-0) > 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>54868-0016-00</NDC11Code>
<ProductNDC>54868-0016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dulcolax</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100519</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54868-0017-1</NDCCode>
<PackageDescription>10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-1)</PackageDescription>
<NDC11Code>54868-0017-01</NDC11Code>
<ProductNDC>54868-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niaspan</ProprietaryName>
<NonProprietaryName>Niacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020381</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>NIACIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.</IndicationAndUsage>
<Description>NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-0017-2</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-2)</PackageDescription>
<NDC11Code>54868-0017-02</NDC11Code>
<ProductNDC>54868-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niaspan</ProprietaryName>
<NonProprietaryName>Niacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020381</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>NIACIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.</IndicationAndUsage>
<Description>NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-0017-5</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-5)</PackageDescription>
<NDC11Code>54868-0017-05</NDC11Code>
<ProductNDC>54868-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niaspan</ProprietaryName>
<NonProprietaryName>Niacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020381</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>NIACIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.</IndicationAndUsage>
<Description>NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-0017-6</NDCCode>
<PackageDescription>180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-6)</PackageDescription>
<NDC11Code>54868-0017-06</NDC11Code>
<ProductNDC>54868-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Niaspan</ProprietaryName>
<NonProprietaryName>Niacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020381</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>NIACIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.</IndicationAndUsage>
<Description>NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-0018-1</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (54868-0018-1)</PackageDescription>
<NDC11Code>54868-0018-01</NDC11Code>
<ProductNDC>54868-0018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin Ethylsuccinate</ProprietaryName>
<NonProprietaryName>Erythromycin Ethylsuccinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061904</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>ERYTHROMYCIN ETHYLSUCCINATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
</NDC>
<NDC>
<NDCCode>54868-0018-9</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (54868-0018-9)</PackageDescription>
<NDC11Code>54868-0018-09</NDC11Code>
<ProductNDC>54868-0018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin Ethylsuccinate</ProprietaryName>
<NonProprietaryName>Erythromycin Ethylsuccinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061904</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>ERYTHROMYCIN ETHYLSUCCINATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
</NDC>
<NDC>
<NDCCode>54868-0021-0</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (54868-0021-0)</PackageDescription>
<NDC11Code>54868-0021-00</NDC11Code>
<ProductNDC>54868-0021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090624</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-0021-1</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (54868-0021-1)</PackageDescription>
<NDC11Code>54868-0021-01</NDC11Code>
<ProductNDC>54868-0021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090624</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>