{
"NDC": [
{
"NDCCode": "83938-665-05",
"PackageDescription": "1 PAIL in 1 BOX (83938-665-05) / 5 kg in 1 PAIL",
"NDC11Code": "83938-0665-05",
"ProductNDC": "83938-665",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Benzocaine, Lidocaine Hydrochloride, And Tetracaine Hydrochloride",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20240215",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "LYNEX Cosmotech Lab Mfg Inc.",
"SubstanceName": "BENZOCAINE; LIDOCAINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE",
"StrengthNumber": "50; 20; 20",
"StrengthUnit": "g/kg; g/kg; g/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-FEB-24"
},
{
"NDCCode": "83938-674-05",
"PackageDescription": "1 PAIL in 1 BOX (83938-674-05) / 5 kg in 1 PAIL",
"NDC11Code": "83938-0674-05",
"ProductNDC": "83938-674",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Lidocaine Hydrochloride, Tetracaine Hydrochloride, And Racepinephrine Hydrochloride",
"DosageFormName": "GEL",
"StartMarketingDate": "20240215",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "LYNEX Cosmotech Lab Mfg Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; RACEPINEPHRINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE",
"StrengthNumber": "50; 200; 20",
"StrengthUnit": "g/kg; mg/kg; g/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-FEB-24"
},
{
"NDCCode": "83938-677-05",
"PackageDescription": "1 PAIL in 1 BOX (83938-677-05) / 5 kg in 1 PAIL",
"NDC11Code": "83938-0677-05",
"ProductNDC": "83938-677",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Lidocaine Hydrochloride, Tetracaine Hydrochloride, And Racepinephrine Hydrochloride",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20240215",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "LYNEX Cosmotech Lab Mfg Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; RACEPINEPHRINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE",
"StrengthNumber": "50; 200; 20",
"StrengthUnit": "g/kg; mg/kg; g/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-FEB-24"
},
{
"NDCCode": "10135-665-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (10135-665-05) ",
"NDC11Code": "10135-0665-05",
"ProductNDC": "10135-665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208507",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1- carbamate and has the empirical formula C 11 H 15 NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film- coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contains Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material."
},
{
"NDCCode": "49035-665-05",
"PackageDescription": "1 g in 1 CONTAINER (49035-665-05) ",
"NDC11Code": "49035-0665-05",
"ProductNDC": "49035-665",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Moisture Spf 15 Lip Balm",
"NonProprietaryName": "Oxybenzone, Octinoxate, Petrolatum",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Walmart",
"SubstanceName": "OCTINOXATE; OXYBENZONE; PETROLATUM",
"StrengthNumber": "7.5; 3.5; 40.7",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips."
},
{
"NDCCode": "51486-018-05",
"PackageDescription": "665 L in 1 CYLINDER (51486-018-05) ",
"NDC11Code": "51486-0018-05",
"ProductNDC": "51486-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Air",
"NonProprietaryName": "Air",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205865",
"LabelerName": "ILMO Products Company",
"SubstanceName": "OXYGEN",
"StrengthNumber": "210",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090101",
"SamplePackage": "N"
},
{
"NDCCode": "55111-665-05",
"PackageDescription": "500 CAPSULE, LIQUID FILLED in 1 BOTTLE (55111-665-05)",
"NDC11Code": "55111-0665-05",
"ProductNDC": "55111-665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paricalcitol",
"NonProprietaryName": "Paricalcitol",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20140625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091412",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "PARICALCITOL",
"StrengthNumber": "4",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2017-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140625",
"SamplePackage": "N",
"Description": "Paricalcitol USP, the active ingredient in paricalcitol capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Paricalcitol capsules are available as hard gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each capsule also contains butylated hydroxytoluene, dehydrated ethanol, medium chain triglycerides and polyoxyl 35 castor oil. The medium chain triglycerides are fractionated from coconut oil or palm kernel oil. The capsule shell is composed of gelatin, sodium lauryl sulfate and titanium dioxide. The gelatin solution is composed of gelatin (210 bloom), red iron oxide (for 1 micrograms and 2 micrograms), yellow iron oxide (for 2 micrograms and 4 micrograms) and polysorbate 80. Paricalcitol is a white to almost white powder with the molecular formula of C27H44O3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula."
},
{
"NDCCode": "61314-665-05",
"PackageDescription": "5 mL in 1 BOTTLE (61314-665-05) ",
"NDC11Code": "61314-0665-05",
"ProductNDC": "61314-665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apraclonidine",
"NonProprietaryName": "Apraclonidine",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20090719",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020258",
"LabelerName": "Sandoz Inc",
"SubstanceName": "APRACLONIDINE HYDROCHLORIDE",
"StrengthNumber": "5.75",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090719",
"SamplePackage": "N",
"IndicationAndUsage": "Apraclonidine ophthalmic solution 0.5% is indicated for short-term adjunctive therapy, in patients on maximally tolerated medical therapy, who require additional IOP reduction. Patients on maximally tolerated medical therapy, who are treated with apraclonidine ophthalmic solution 0.5% to delay surgery, should have frequent follow-up examinations and treatment should be discontinued if the IOP rises significantly. The addition of apraclonidine ophthalmic solution 0.5% to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because apraclonidine ophthalmic solution 0.5% is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP. The IOP lowering efficacy of apraclonidine ophthalmic solution 0.5% diminishes over time in some patients. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored. The benefit for most patients is less than one month.",
"Description": "Apraclonidine ophthalmic solution 0.5% contains apraclonidine hydrochloride, an alpha adrenergic agonist, in a sterile isotonic solution for topical application to the eye. Apraclonidine hydrochloride is a white to off-white powder and is highly soluble in water. Its chemical name is 2-[(4-amino-2,6 dichlorophenyl) imino]imidazolidine monohydrochloride with an empirical formula of C 9H 11Cl 3N 4 and a molecular weight of 281.57 g/mol. The chemical structure of apraclonidine hydrochloride is:. Each mL of apraclonidine ophthalmic solution 0.5% contains: Active: apraclonidine hydrochloride 5.75 mg equivalent to apraclonidine base 5 mg. Preservative: benzalkonium chloride 0.01%. Inactives: hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water, sodium acetate, and sodium chloride."
},
{
"NDCCode": "65219-665-05",
"PackageDescription": "10 VIAL in 1 TRAY (65219-665-05) / 5 mL in 1 VIAL (65219-665-01) ",
"NDC11Code": "65219-0665-05",
"ProductNDC": "65219-665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091045",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate injection is indicated in the treatment of definite or suspected acute myocardial infarction in hemodynamically stable patients to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy.",
"Description": "Metoprolol Tartrate Injection, USP, is a selective beta1-adrenoreceptor blocking agent, available in 5-mL vials for intravenous administration. Each vial contains a sterile solution of metoprolol tartrate USP, 5 mg, and sodium chloride USP, 45 mg, and water for injection USP. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2- methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is:. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether."
},
{
"NDCCode": "65841-665-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (65841-665-05) ",
"NDC11Code": "65841-0665-05",
"ProductNDC": "65841-665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078040",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081113",
"SamplePackage": "N"
},
{
"NDCCode": "65862-665-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (65862-665-05) ",
"NDC11Code": "65862-0665-05",
"ProductNDC": "65862-665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203908",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151008",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder , 3 Irritability Associated with Autistic Disorder , 4 Treatment of Tourette’s Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The molecular formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition the 2 mg strength contains FD&C Blue No. 2 and ferric oxide (sicovit yellow 10) and 5 mg contains FD&C Blue No. 2."
},
{
"NDCCode": "67877-665-05",
"PackageDescription": "500 TABLET in 1 CONTAINER (67877-665-05) ",
"NDC11Code": "67877-0665-05",
"ProductNDC": "67877-665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobazam",
"NonProprietaryName": "Clobazam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190907",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212714",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "CLOBAZAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190907",
"SamplePackage": "N",
"IndicationAndUsage": "Clobazam tablet is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.",
"Description": "Table 4. Description. Clobazam is a white or almost white crystalline powder, freely soluble in dichloromethane. The melting range of clobazam is from 178ºC to 185ºC. The molecular formula is C16H13O2N2Cl and the molecular weight is 300.74. Each clobazam tablet contains 5 mg, 10 mg or 20 mg of clobazam. Tablets also contain as inactive ingredients: Pregelatinized starch, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, and talc."
},
{
"NDCCode": "68428-665-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-665-05) ",
"NDC11Code": "68428-0665-05",
"ProductNDC": "68428-665",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tarentula Hispana",
"NonProprietaryName": "Lycosa Tarantula",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "LYCOSA TARANTULA",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "70756-665-05",
"PackageDescription": "5 VIAL in 1 CARTON (70756-665-05) / 30 mL in 1 VIAL",
"NDC11Code": "70756-0665-05",
"ProductNDC": "70756-665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20231129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217692",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231129",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.",
"Description": "Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Lidocaine hydrochloride injection, USP solution contain lidocaine hydrochloride, USP which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine hydrochloride, USP (C14H22N2OHCl) has the following structural formula. Lidocaine hydrochloride injection, USP is a clear, colorless, sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of this solution is adjusted to approximately 5.0 to 7.0 with sodium hydroxide and/or hydrochloric acid."
},
{
"NDCCode": "71205-665-05",
"PackageDescription": "5 TABLET in 1 BOTTLE (71205-665-05) ",
"NDC11Code": "71205-0665-05",
"ProductNDC": "71205-665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211575",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220526",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone Tablets, USP are indicated in the following conditions:Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable, in infancy mineralocorticoid supplementation is of particular importance), Congenital adrenal hyperplasia, Hypercalcemia associated with cancer, nonsuppurative thyroiditisRheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitisCollagen Diseases During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.Dermatologic Diseases Pemphigus, Bullous dermatitis herpetiformis, severe erythema multiforme (stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis.Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis.Respiratory Diseases Symptomatic sarcoidosis, loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis.Hematologic Disorders Idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia.Neoplastic Diseases For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosusGastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritisNervous System Acute exacerbations of multiple sclerosisMiscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone Tablets, USP are available for oral administration containing 2.5 mg, 5 mg, 10 mg, 20 mg and 50 mg of prednisone, USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-. The structural formula is represented below. Molecular Formula: C21H26O5. Molecular Weight: 358.44. Prednisone is a white or almost white crystalline powder. It is slightly soluble in acetone, ethanol, ethylacetate and methanol."
},
{
"NDCCode": "72476-665-05",
"PackageDescription": "355 mL in 1 BOTTLE (72476-665-05) ",
"NDC11Code": "72476-0665-05",
"ProductNDC": "72476-665",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Careone Milk Of Magnesia Cherry",
"NonProprietaryName": "Magnesium Hydroxide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220422",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Retail Business Services, LLC.",
"SubstanceName": "MAGNESIUM HYDROXIDE",
"StrengthNumber": "1200",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220422",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). This product usually produces bowel movement in 1/2 to 6 hours."
},
{
"NDCCode": "72485-665-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (72485-665-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "72485-0665-05",
"ProductNDC": "72485-665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loteprednol Etabonate",
"NonProprietaryName": "Loteprednol Etabonate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20231026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207609",
"LabelerName": "ARMAS PHARMACEUTICALS INC.",
"SubstanceName": "LOTEPREDNOL ETABONATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231026",
"SamplePackage": "N",
"IndicationAndUsage": "Loteprednol etabonate 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. Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate 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 loteprednol etabonate and 6% with prednisolone acetate 1%. Loteprednol etabonate should not be used in patients who require a more potent corticosteroid for this indication. Loteprednol etabonate is also indicated for the treatment of post-operative inflammation following ocular surgery.",
"Description": "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. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 5 mg (0.5%);. INACTIVES: Edetate disodium, glycerin, povidone K-30, purified water sodium hydroxide and tyloxapol. Hydrochloric acid may be added to adjust the pH to 5.0 - 6.0. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium chloride 0.01%."
},
{
"NDCCode": "84522-665-05",
"PackageDescription": "100 g in 1 BOX (84522-665-05) ",
"NDC11Code": "84522-0665-05",
"ProductNDC": "84522-665",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acid Cream",
"NonProprietaryName": "Acid Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250107",
"EndMarketingDate": "20310107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250107",
"EndMarketingDatePackage": "20310107",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "41500-002-01",
"PackageDescription": "350 mL in 1 BOTTLE (41500-002-01) ",
"NDC11Code": "41500-0002-01",
"ProductNDC": "41500-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Runyi Miaojie Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "LIQUID",
"RouteName": "EXTRACORPOREAL",
"StartMarketingDate": "20200321",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Beijing Runyi Technology Co., Ltd",
"SubstanceName": "ALCOHOL; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; SILVER CATION; TROLAMINE; PROPYLENE GLYCOL",
"StrengthNumber": "66.5; .665; 1.75; 1.05; 17.5",
"StrengthUnit": "mL/350mL; mg/350mL; mg/350mL; mg/350mL; mg/350mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200321",
"SamplePackage": "N",
"IndicationAndUsage": "Take appropriate amount of this product to moisten your hands and rub for one minute until the liquid covers the whole surface."
},
{
"NDCCode": "43598-624-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (43598-624-30) ",
"NDC11Code": "43598-0624-30",
"ProductNDC": "43598-624",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine And Topiramate Extended-release",
"NonProprietaryName": "Phentermine And Topiramate Extended-release",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208175",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE; TOPIRAMATE",
"StrengthNumber": "3.75; 23",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: 1 Adult patients with obesity, 2 Adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "Phentermine and topiramate extended-release capsules are comprised of immediate-release phentermine hydrochloride, USP (expressed as the weight of the free base) and extended-release topiramate, USP. Phentermine and topiramate extended-release capsules contain phentermine hydrochloride, USP, a sympathomimetic amine anorectic, and topiramate, USP, a sulfamate-substituted monosaccharide. Phentermine Hydrochloride, USP. The chemical name of phentermine hydrochloride, USP is α,α-dimethylphenethylamine hydrochloride. The molecular formula is C10H16ClN and its molecular weight is 185.69 g mol-1 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride, USP is a white, odourless, hygroscopic, crystalline powder that is soluble in water and lower alcohols. It is also slightly soluble in chloroform and insoluble in ether. Its structural formula is. Topiramate, USP. Topiramate, USP is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C12H21NO8S and its molecular weight is 339.36.Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Its structural formula is. Phentermine and Topiramate Extended-Release Capsules. Phentermine and topiramate extended-release capsules are for oral administration and available in four dosage strengths:. 3.75 mg/23 mg (phentermine 3.75 mg and topiramate USP, 23 mg) (equivalent to 4.665 mg of Phentermine Hydrochloride, USP). 7.5 mg/46 mg (phentermine 7.5 mg and topiramate USP, 46 mg) (equivalent to 9.33 mg of Phentermine Hydrochloride, USP). 11.25 mg/69 mg (phentermine 11.25 mg and topiramate USP, 69 mg) (equivalent to 14 mg of Phentermine Hydrochloride, USP). 15 mg/92 mg (phentermine 15 mg and topiramate USP, 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride, USP). Each capsule contains the following inactive ingredients: ethocel, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, talc and titanium dioxide. In addition, the 7.5 mg/46 mg contains FD&C Red No. 40 and FD&C Yellow #6, 11.25 mg/69 mg contains FD&C Yellow #5 and FD&C Blue #1, 15 mg/92 mg contains FD&C Yellow #6 and D&C Red #28. The imprinting ink opacode Black contains shellac, iron oxide black, propylene glycol, FD&C Blue #2, FD&C Red No. 40, D&C Yellow #10, FD&C Blue #1."
},
{
"NDCCode": "43598-625-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (43598-625-30) ",
"NDC11Code": "43598-0625-30",
"ProductNDC": "43598-625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine And Topiramate Extended-release",
"NonProprietaryName": "Phentermine And Topiramate Extended-release",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208175",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE; TOPIRAMATE",
"StrengthNumber": "7.5; 46",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: 1 Adult patients with obesity, 2 Adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "Phentermine and topiramate extended-release capsules are comprised of immediate-release phentermine hydrochloride, USP (expressed as the weight of the free base) and extended-release topiramate, USP. Phentermine and topiramate extended-release capsules contain phentermine hydrochloride, USP, a sympathomimetic amine anorectic, and topiramate, USP, a sulfamate-substituted monosaccharide. Phentermine Hydrochloride, USP. The chemical name of phentermine hydrochloride, USP is α,α-dimethylphenethylamine hydrochloride. The molecular formula is C10H16ClN and its molecular weight is 185.69 g mol-1 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride, USP is a white, odourless, hygroscopic, crystalline powder that is soluble in water and lower alcohols. It is also slightly soluble in chloroform and insoluble in ether. Its structural formula is. Topiramate, USP. Topiramate, USP is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C12H21NO8S and its molecular weight is 339.36.Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Its structural formula is. Phentermine and Topiramate Extended-Release Capsules. Phentermine and topiramate extended-release capsules are for oral administration and available in four dosage strengths:. 3.75 mg/23 mg (phentermine 3.75 mg and topiramate USP, 23 mg) (equivalent to 4.665 mg of Phentermine Hydrochloride, USP). 7.5 mg/46 mg (phentermine 7.5 mg and topiramate USP, 46 mg) (equivalent to 9.33 mg of Phentermine Hydrochloride, USP). 11.25 mg/69 mg (phentermine 11.25 mg and topiramate USP, 69 mg) (equivalent to 14 mg of Phentermine Hydrochloride, USP). 15 mg/92 mg (phentermine 15 mg and topiramate USP, 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride, USP). Each capsule contains the following inactive ingredients: ethocel, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, talc and titanium dioxide. In addition, the 7.5 mg/46 mg contains FD&C Red No. 40 and FD&C Yellow #6, 11.25 mg/69 mg contains FD&C Yellow #5 and FD&C Blue #1, 15 mg/92 mg contains FD&C Yellow #6 and D&C Red #28. The imprinting ink opacode Black contains shellac, iron oxide black, propylene glycol, FD&C Blue #2, FD&C Red No. 40, D&C Yellow #10, FD&C Blue #1."
},
{
"NDCCode": "43598-626-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (43598-626-30) ",
"NDC11Code": "43598-0626-30",
"ProductNDC": "43598-626",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine And Topiramate Extended-release",
"NonProprietaryName": "Phentermine And Topiramate Extended-release",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208175",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE; TOPIRAMATE",
"StrengthNumber": "11.25; 69",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: 1 Adult patients with obesity, 2 Adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "Phentermine and topiramate extended-release capsules are comprised of immediate-release phentermine hydrochloride, USP (expressed as the weight of the free base) and extended-release topiramate, USP. Phentermine and topiramate extended-release capsules contain phentermine hydrochloride, USP, a sympathomimetic amine anorectic, and topiramate, USP, a sulfamate-substituted monosaccharide. Phentermine Hydrochloride, USP. The chemical name of phentermine hydrochloride, USP is α,α-dimethylphenethylamine hydrochloride. The molecular formula is C10H16ClN and its molecular weight is 185.69 g mol-1 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride, USP is a white, odourless, hygroscopic, crystalline powder that is soluble in water and lower alcohols. It is also slightly soluble in chloroform and insoluble in ether. Its structural formula is. Topiramate, USP. Topiramate, USP is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C12H21NO8S and its molecular weight is 339.36.Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Its structural formula is. Phentermine and Topiramate Extended-Release Capsules. Phentermine and topiramate extended-release capsules are for oral administration and available in four dosage strengths:. 3.75 mg/23 mg (phentermine 3.75 mg and topiramate USP, 23 mg) (equivalent to 4.665 mg of Phentermine Hydrochloride, USP). 7.5 mg/46 mg (phentermine 7.5 mg and topiramate USP, 46 mg) (equivalent to 9.33 mg of Phentermine Hydrochloride, USP). 11.25 mg/69 mg (phentermine 11.25 mg and topiramate USP, 69 mg) (equivalent to 14 mg of Phentermine Hydrochloride, USP). 15 mg/92 mg (phentermine 15 mg and topiramate USP, 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride, USP). Each capsule contains the following inactive ingredients: ethocel, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, talc and titanium dioxide. In addition, the 7.5 mg/46 mg contains FD&C Red No. 40 and FD&C Yellow #6, 11.25 mg/69 mg contains FD&C Yellow #5 and FD&C Blue #1, 15 mg/92 mg contains FD&C Yellow #6 and D&C Red #28. The imprinting ink opacode Black contains shellac, iron oxide black, propylene glycol, FD&C Blue #2, FD&C Red No. 40, D&C Yellow #10, FD&C Blue #1."
},
{
"NDCCode": "43598-627-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (43598-627-30) ",
"NDC11Code": "43598-0627-30",
"ProductNDC": "43598-627",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine And Topiramate Extended-release",
"NonProprietaryName": "Phentermine And Topiramate Extended-release",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208175",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE; TOPIRAMATE",
"StrengthNumber": "15; 92",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: 1 Adult patients with obesity, 2 Adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "Phentermine and topiramate extended-release capsules are comprised of immediate-release phentermine hydrochloride, USP (expressed as the weight of the free base) and extended-release topiramate, USP. Phentermine and topiramate extended-release capsules contain phentermine hydrochloride, USP, a sympathomimetic amine anorectic, and topiramate, USP, a sulfamate-substituted monosaccharide. Phentermine Hydrochloride, USP. The chemical name of phentermine hydrochloride, USP is α,α-dimethylphenethylamine hydrochloride. The molecular formula is C10H16ClN and its molecular weight is 185.69 g mol-1 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride, USP is a white, odourless, hygroscopic, crystalline powder that is soluble in water and lower alcohols. It is also slightly soluble in chloroform and insoluble in ether. Its structural formula is. Topiramate, USP. Topiramate, USP is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C12H21NO8S and its molecular weight is 339.36.Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Its structural formula is. Phentermine and Topiramate Extended-Release Capsules. Phentermine and topiramate extended-release capsules are for oral administration and available in four dosage strengths:. 3.75 mg/23 mg (phentermine 3.75 mg and topiramate USP, 23 mg) (equivalent to 4.665 mg of Phentermine Hydrochloride, USP). 7.5 mg/46 mg (phentermine 7.5 mg and topiramate USP, 46 mg) (equivalent to 9.33 mg of Phentermine Hydrochloride, USP). 11.25 mg/69 mg (phentermine 11.25 mg and topiramate USP, 69 mg) (equivalent to 14 mg of Phentermine Hydrochloride, USP). 15 mg/92 mg (phentermine 15 mg and topiramate USP, 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride, USP). Each capsule contains the following inactive ingredients: ethocel, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, talc and titanium dioxide. In addition, the 7.5 mg/46 mg contains FD&C Red No. 40 and FD&C Yellow #6, 11.25 mg/69 mg contains FD&C Yellow #5 and FD&C Blue #1, 15 mg/92 mg contains FD&C Yellow #6 and D&C Red #28. The imprinting ink opacode Black contains shellac, iron oxide black, propylene glycol, FD&C Blue #2, FD&C Red No. 40, D&C Yellow #10, FD&C Blue #1."
},
{
"NDCCode": "46122-665-15",
"PackageDescription": "3 CONTAINER in 1 CARTON (46122-665-15) > 27 LOZENGE in 1 CONTAINER",
"NDC11Code": "46122-0665-15",
"ProductNDC": "46122-665",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Nicotine Mini",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20201204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203690",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201204",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "51316-666-07",
"PackageDescription": "1 KIT in 1 PACKAGE (51316-666-07) * 236 mL in 1 BOTTLE (51316-665-06) * 236 mL in 1 BOTTLE (51316-664-06) ",
"NDC11Code": "51316-0666-07",
"ProductNDC": "51316-666",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime And Nighttime High Blood Pressure Cold And Flu Liquid",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr And Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20250421",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "CVS Pharmacy, Inc.",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250421",
"SamplePackage": "N"
},
{
"NDCCode": "55700-665-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (55700-665-30) ",
"NDC11Code": "55700-0665-30",
"ProductNDC": "55700-665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204319",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180810",
"SamplePackage": "N"
},
{
"NDCCode": "58468-0251-5",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (58468-0251-5) / 28 TABLET, FILM COATED in 1 BLISTER PACK (58468-0251-0) ",
"NDC11Code": "58468-0251-05",
"ProductNDC": "58468-0251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wayrilz",
"NonProprietaryName": "Rilzabrutinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250829",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219685",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "RILZABRUTINIB",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250829",
"SamplePackage": "N",
"IndicationAndUsage": "WAYRILZ is indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.",
"Description": "WAYRILZ (rilzabrutinib) is a kinase inhibitor. Rilzabrutinib is a white to off-white solid, which is freely soluble in ethanol, sparingly soluble in isopropyl alcohol and practically insoluble in water. The chemical name for rilzabrutinib is 1-Piperidinepropanenitrile, 3-[4-amino-3-(2-fluoro-4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-α-[2-methyl-2-[4-(3-oxetanyl)-1-piperazinyl]propylidene]-β-oxo-, (3R)-. The molecular formula is C36H40FN9O3 and the molecular weight is 665.77 Daltons. The chemical structural formula of rilzabrutinib is shown below. Each WAYRILZ film-coated tablet for oral administration contains 400 mg rilzabrutinib. The inactive ingredients in the tablet core are crospovidone (Type A), microcrystalline cellulose, and sodium stearyl fumarate. The inactive ingredients in the tablet coating are FD&C yellow #6/Sunset yellow FCF aluminum lake, macrogol/polyethylene glycol (PEG), polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide."
},
{
"NDCCode": "60429-665-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (60429-665-01) ",
"NDC11Code": "60429-0665-01",
"ProductNDC": "60429-665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091182",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160203",
"SamplePackage": "N",
"IndicationAndUsage": "For use as adjunctive therapy in the treatment of peptic ulcer.",
"Description": "Glycopyrrolate tablets contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide. Each glycopyrrolate tablet USP, intended for oral administration, contains glycopyrrolate equivalent to 1 mg or 2 mg. In addition, it also contains the following inactive ingredients: lactose monohydrate, dibasic calcium phosphate anhydrous, povidone, sodium starch glycolate and magnesium stearate. The structural formula of glycopyrrolate is represented below. Molecular Formula: C 19H 28BrNO 3 Molecular Weight: 398.33. Each tablet contains 1 mg or 2 mg of Glycopyrrolate, USP. Inactive Ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "60505-0845-5",
"PackageDescription": "1 BOTTLE in 1 CARTON (60505-0845-5) / 240 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "60505-0845-05",
"ProductNDC": "60505-0845",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olopatadine Hydrochloride",
"NonProprietaryName": "Olopatadine Hydrochloride",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20141027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091572",
"LabelerName": "Apotex Corp.",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE",
"StrengthNumber": "665",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141027",
"SamplePackage": "N",
"IndicationAndUsage": "Olopatadine hydrochloride nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.",
"Description": "Olopatadine Hydrochloride Nasal Spray, 665 micrograms (mcg) is a metered-spray for nasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Spray, is a white to off-white, water-soluble crystalline powder. The chemical name for olopatadine hydrochloride is (Z)-11-[3-(dimethylamino)propylidene]-6,11-dihydrodibenz[b,e] oxepin-2-acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3 HCl with the following chemical structure:. Olopatadine Hydrochloride Nasal Spray contains 0.6% w/v olopatadine (base) in a nonsterile aqueous spray with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous spray containing 665 mcg of olopatadine hydrochloride, which is equivalent to 600 mcg of olopatadine (base) [see Dosage Forms and Strengths (3)]. Olopatadine Hydrochloride Nasal Spray also contains anhydrous dibasic sodium phosphate, benzalkonium chloride (0.01%), edetate disodium dihydrate, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water."
},
{
"NDCCode": "61010-1112-5",
"PackageDescription": ".118 L in 1 BOTTLE (61010-1112-5) ",
"NDC11Code": "61010-1112-05",
"ProductNDC": "61010-1112",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120322",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Safetec of America, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "665",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120322",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on skin without soap and water. recommended for repeated use."
}
]
}
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<NDC>
<NDCCode>83938-665-05</NDCCode>
<PackageDescription>1 PAIL in 1 BOX (83938-665-05) / 5 kg in 1 PAIL</PackageDescription>
<NDC11Code>83938-0665-05</NDC11Code>
<ProductNDC>83938-665</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Benzocaine, Lidocaine Hydrochloride, And Tetracaine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20240215</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>LYNEX Cosmotech Lab Mfg Inc.</LabelerName>
<SubstanceName>BENZOCAINE; LIDOCAINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; 20; 20</StrengthNumber>
<StrengthUnit>g/kg; g/kg; g/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-FEB-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>83938-674-05</NDCCode>
<PackageDescription>1 PAIL in 1 BOX (83938-674-05) / 5 kg in 1 PAIL</PackageDescription>
<NDC11Code>83938-0674-05</NDC11Code>
<ProductNDC>83938-674</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Lidocaine Hydrochloride, Tetracaine Hydrochloride, And Racepinephrine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<StartMarketingDate>20240215</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>LYNEX Cosmotech Lab Mfg Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; RACEPINEPHRINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; 200; 20</StrengthNumber>
<StrengthUnit>g/kg; mg/kg; g/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-FEB-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>83938-677-05</NDCCode>
<PackageDescription>1 PAIL in 1 BOX (83938-677-05) / 5 kg in 1 PAIL</PackageDescription>
<NDC11Code>83938-0677-05</NDC11Code>
<ProductNDC>83938-677</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Lidocaine Hydrochloride, Tetracaine Hydrochloride, And Racepinephrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20240215</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>LYNEX Cosmotech Lab Mfg Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; RACEPINEPHRINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; 200; 20</StrengthNumber>
<StrengthUnit>g/kg; mg/kg; g/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-FEB-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>10135-665-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (10135-665-05) </PackageDescription>
<NDC11Code>10135-0665-05</NDC11Code>
<ProductNDC>10135-665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208507</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1- carbamate and has the empirical formula C 11 H 15 NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film- coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contains Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material.</Description>
</NDC>
<NDC>
<NDCCode>49035-665-05</NDCCode>
<PackageDescription>1 g in 1 CONTAINER (49035-665-05) </PackageDescription>
<NDC11Code>49035-0665-05</NDC11Code>
<ProductNDC>49035-665</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Moisture Spf 15 Lip Balm</ProprietaryName>
<NonProprietaryName>Oxybenzone, Octinoxate, Petrolatum</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Walmart</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE; PETROLATUM</SubstanceName>
<StrengthNumber>7.5; 3.5; 40.7</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51486-018-05</NDCCode>
<PackageDescription>665 L in 1 CYLINDER (51486-018-05) </PackageDescription>
<NDC11Code>51486-0018-05</NDC11Code>
<ProductNDC>51486-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Air</ProprietaryName>
<NonProprietaryName>Air</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205865</ApplicationNumber>
<LabelerName>ILMO Products Company</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>210</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55111-665-05</NDCCode>
<PackageDescription>500 CAPSULE, LIQUID FILLED in 1 BOTTLE (55111-665-05)</PackageDescription>
<NDC11Code>55111-0665-05</NDC11Code>
<ProductNDC>55111-665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paricalcitol</ProprietaryName>
<NonProprietaryName>Paricalcitol</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091412</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>PARICALCITOL</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Paricalcitol USP, the active ingredient in paricalcitol capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Paricalcitol capsules are available as hard gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each capsule also contains butylated hydroxytoluene, dehydrated ethanol, medium chain triglycerides and polyoxyl 35 castor oil. The medium chain triglycerides are fractionated from coconut oil or palm kernel oil. The capsule shell is composed of gelatin, sodium lauryl sulfate and titanium dioxide. The gelatin solution is composed of gelatin (210 bloom), red iron oxide (for 1 micrograms and 2 micrograms), yellow iron oxide (for 2 micrograms and 4 micrograms) and polysorbate 80. Paricalcitol is a white to almost white powder with the molecular formula of C27H44O3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>61314-665-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE (61314-665-05) </PackageDescription>
<NDC11Code>61314-0665-05</NDC11Code>
<ProductNDC>61314-665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apraclonidine</ProprietaryName>
<NonProprietaryName>Apraclonidine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20090719</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020258</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>APRACLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5.75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apraclonidine ophthalmic solution 0.5% is indicated for short-term adjunctive therapy, in patients on maximally tolerated medical therapy, who require additional IOP reduction. Patients on maximally tolerated medical therapy, who are treated with apraclonidine ophthalmic solution 0.5% to delay surgery, should have frequent follow-up examinations and treatment should be discontinued if the IOP rises significantly. The addition of apraclonidine ophthalmic solution 0.5% to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because apraclonidine ophthalmic solution 0.5% is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP. The IOP lowering efficacy of apraclonidine ophthalmic solution 0.5% diminishes over time in some patients. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored. The benefit for most patients is less than one month.</IndicationAndUsage>
<Description>Apraclonidine ophthalmic solution 0.5% contains apraclonidine hydrochloride, an alpha adrenergic agonist, in a sterile isotonic solution for topical application to the eye. Apraclonidine hydrochloride is a white to off-white powder and is highly soluble in water. Its chemical name is 2-[(4-amino-2,6 dichlorophenyl) imino]imidazolidine monohydrochloride with an empirical formula of C 9H 11Cl 3N 4 and a molecular weight of 281.57 g/mol. The chemical structure of apraclonidine hydrochloride is:. Each mL of apraclonidine ophthalmic solution 0.5% contains: Active: apraclonidine hydrochloride 5.75 mg equivalent to apraclonidine base 5 mg. Preservative: benzalkonium chloride 0.01%. Inactives: hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water, sodium acetate, and sodium chloride.</Description>
</NDC>
<NDC>
<NDCCode>65219-665-05</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (65219-665-05) / 5 mL in 1 VIAL (65219-665-01) </PackageDescription>
<NDC11Code>65219-0665-05</NDC11Code>
<ProductNDC>65219-665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091045</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate injection is indicated in the treatment of definite or suspected acute myocardial infarction in hemodynamically stable patients to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy.</IndicationAndUsage>
<Description>Metoprolol Tartrate Injection, USP, is a selective beta1-adrenoreceptor blocking agent, available in 5-mL vials for intravenous administration. Each vial contains a sterile solution of metoprolol tartrate USP, 5 mg, and sodium chloride USP, 45 mg, and water for injection USP. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-(2- methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is:. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>65841-665-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (65841-665-05) </PackageDescription>
<NDC11Code>65841-0665-05</NDC11Code>
<ProductNDC>65841-665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078040</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65862-665-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (65862-665-05) </PackageDescription>
<NDC11Code>65862-0665-05</NDC11Code>
<ProductNDC>65862-665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203908</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder , 3 Irritability Associated with Autistic Disorder , 4 Treatment of Tourette’s Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The molecular formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition the 2 mg strength contains FD&C Blue No. 2 and ferric oxide (sicovit yellow 10) and 5 mg contains FD&C Blue No. 2.</Description>
</NDC>
<NDC>
<NDCCode>67877-665-05</NDCCode>
<PackageDescription>500 TABLET in 1 CONTAINER (67877-665-05) </PackageDescription>
<NDC11Code>67877-0665-05</NDC11Code>
<ProductNDC>67877-665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobazam</ProprietaryName>
<NonProprietaryName>Clobazam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190907</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212714</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>CLOBAZAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190907</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobazam tablet is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.</IndicationAndUsage>
<Description>Table 4. Description. Clobazam is a white or almost white crystalline powder, freely soluble in dichloromethane. The melting range of clobazam is from 178ºC to 185ºC. The molecular formula is C16H13O2N2Cl and the molecular weight is 300.74. Each clobazam tablet contains 5 mg, 10 mg or 20 mg of clobazam. Tablets also contain as inactive ingredients: Pregelatinized starch, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, and talc.</Description>
</NDC>
<NDC>
<NDCCode>68428-665-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-665-05) </PackageDescription>
<NDC11Code>68428-0665-05</NDC11Code>
<ProductNDC>68428-665</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tarentula Hispana</ProprietaryName>
<NonProprietaryName>Lycosa Tarantula</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>LYCOSA TARANTULA</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70756-665-05</NDCCode>
<PackageDescription>5 VIAL in 1 CARTON (70756-665-05) / 30 mL in 1 VIAL</PackageDescription>
<NDC11Code>70756-0665-05</NDC11Code>
<ProductNDC>70756-665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20231129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217692</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
<Description>Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Lidocaine hydrochloride injection, USP solution contain lidocaine hydrochloride, USP which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine hydrochloride, USP (C14H22N2OHCl) has the following structural formula. Lidocaine hydrochloride injection, USP is a clear, colorless, sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of this solution is adjusted to approximately 5.0 to 7.0 with sodium hydroxide and/or hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>71205-665-05</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE (71205-665-05) </PackageDescription>
<NDC11Code>71205-0665-05</NDC11Code>
<ProductNDC>71205-665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211575</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone Tablets, USP are indicated in the following conditions:Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable, in infancy mineralocorticoid supplementation is of particular importance), Congenital adrenal hyperplasia, Hypercalcemia associated with cancer, nonsuppurative thyroiditisRheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitisCollagen Diseases During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.Dermatologic Diseases Pemphigus, Bullous dermatitis herpetiformis, severe erythema multiforme (stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis.Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis.Respiratory Diseases Symptomatic sarcoidosis, loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis.Hematologic Disorders Idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia.Neoplastic Diseases For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosusGastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritisNervous System Acute exacerbations of multiple sclerosisMiscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone Tablets, USP are available for oral administration containing 2.5 mg, 5 mg, 10 mg, 20 mg and 50 mg of prednisone, USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-. The structural formula is represented below. Molecular Formula: C21H26O5. Molecular Weight: 358.44. Prednisone is a white or almost white crystalline powder. It is slightly soluble in acetone, ethanol, ethylacetate and methanol.</Description>
</NDC>
<NDC>
<NDCCode>72476-665-05</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (72476-665-05) </PackageDescription>
<NDC11Code>72476-0665-05</NDC11Code>
<ProductNDC>72476-665</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Careone Milk Of Magnesia Cherry</ProprietaryName>
<NonProprietaryName>Magnesium Hydroxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220422</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Retail Business Services, LLC.</LabelerName>
<SubstanceName>MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). This product usually produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72485-665-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (72485-665-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>72485-0665-05</NDC11Code>
<ProductNDC>72485-665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loteprednol Etabonate</ProprietaryName>
<NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20231026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207609</ApplicationNumber>
<LabelerName>ARMAS PHARMACEUTICALS INC.</LabelerName>
<SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loteprednol etabonate 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. Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate 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 loteprednol etabonate and 6% with prednisolone acetate 1%. Loteprednol etabonate should not be used in patients who require a more potent corticosteroid for this indication. Loteprednol etabonate is also indicated for the treatment of post-operative inflammation following ocular surgery.</IndicationAndUsage>
<Description>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. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 5 mg (0.5%);. INACTIVES: Edetate disodium, glycerin, povidone K-30, purified water sodium hydroxide and tyloxapol. Hydrochloric acid may be added to adjust the pH to 5.0 - 6.0. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium chloride 0.01%.</Description>
</NDC>
<NDC>
<NDCCode>84522-665-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84522-665-05) </PackageDescription>
<NDC11Code>84522-0665-05</NDC11Code>
<ProductNDC>84522-665</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acid Cream</ProprietaryName>
<NonProprietaryName>Acid Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250107</StartMarketingDate>
<EndMarketingDate>20310107</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250107</StartMarketingDatePackage>
<EndMarketingDatePackage>20310107</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41500-002-01</NDCCode>
<PackageDescription>350 mL in 1 BOTTLE (41500-002-01) </PackageDescription>
<NDC11Code>41500-0002-01</NDC11Code>
<ProductNDC>41500-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Runyi Miaojie Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>EXTRACORPOREAL</RouteName>
<StartMarketingDate>20200321</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Beijing Runyi Technology Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; SILVER CATION; TROLAMINE; PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>66.5; .665; 1.75; 1.05; 17.5</StrengthNumber>
<StrengthUnit>mL/350mL; mg/350mL; mg/350mL; mg/350mL; mg/350mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Take appropriate amount of this product to moisten your hands and rub for one minute until the liquid covers the whole surface.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-624-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (43598-624-30) </PackageDescription>
<NDC11Code>43598-0624-30</NDC11Code>
<ProductNDC>43598-624</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine And Topiramate Extended-release</ProprietaryName>
<NonProprietaryName>Phentermine And Topiramate Extended-release</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208175</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE; TOPIRAMATE</SubstanceName>
<StrengthNumber>3.75; 23</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: 1 Adult patients with obesity, 2 Adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>Phentermine and topiramate extended-release capsules are comprised of immediate-release phentermine hydrochloride, USP (expressed as the weight of the free base) and extended-release topiramate, USP. Phentermine and topiramate extended-release capsules contain phentermine hydrochloride, USP, a sympathomimetic amine anorectic, and topiramate, USP, a sulfamate-substituted monosaccharide. Phentermine Hydrochloride, USP. The chemical name of phentermine hydrochloride, USP is α,α-dimethylphenethylamine hydrochloride. The molecular formula is C10H16ClN and its molecular weight is 185.69 g mol-1 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride, USP is a white, odourless, hygroscopic, crystalline powder that is soluble in water and lower alcohols. It is also slightly soluble in chloroform and insoluble in ether. Its structural formula is. Topiramate, USP. Topiramate, USP is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C12H21NO8S and its molecular weight is 339.36.Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Its structural formula is. Phentermine and Topiramate Extended-Release Capsules. Phentermine and topiramate extended-release capsules are for oral administration and available in four dosage strengths:. 3.75 mg/23 mg (phentermine 3.75 mg and topiramate USP, 23 mg) (equivalent to 4.665 mg of Phentermine Hydrochloride, USP). 7.5 mg/46 mg (phentermine 7.5 mg and topiramate USP, 46 mg) (equivalent to 9.33 mg of Phentermine Hydrochloride, USP). 11.25 mg/69 mg (phentermine 11.25 mg and topiramate USP, 69 mg) (equivalent to 14 mg of Phentermine Hydrochloride, USP). 15 mg/92 mg (phentermine 15 mg and topiramate USP, 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride, USP). Each capsule contains the following inactive ingredients: ethocel, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, talc and titanium dioxide. In addition, the 7.5 mg/46 mg contains FD&C Red No. 40 and FD&C Yellow #6, 11.25 mg/69 mg contains FD&C Yellow #5 and FD&C Blue #1, 15 mg/92 mg contains FD&C Yellow #6 and D&C Red #28. The imprinting ink opacode Black contains shellac, iron oxide black, propylene glycol, FD&C Blue #2, FD&C Red No. 40, D&C Yellow #10, FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>43598-625-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (43598-625-30) </PackageDescription>
<NDC11Code>43598-0625-30</NDC11Code>
<ProductNDC>43598-625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine And Topiramate Extended-release</ProprietaryName>
<NonProprietaryName>Phentermine And Topiramate Extended-release</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208175</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE; TOPIRAMATE</SubstanceName>
<StrengthNumber>7.5; 46</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: 1 Adult patients with obesity, 2 Adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>Phentermine and topiramate extended-release capsules are comprised of immediate-release phentermine hydrochloride, USP (expressed as the weight of the free base) and extended-release topiramate, USP. Phentermine and topiramate extended-release capsules contain phentermine hydrochloride, USP, a sympathomimetic amine anorectic, and topiramate, USP, a sulfamate-substituted monosaccharide. Phentermine Hydrochloride, USP. The chemical name of phentermine hydrochloride, USP is α,α-dimethylphenethylamine hydrochloride. The molecular formula is C10H16ClN and its molecular weight is 185.69 g mol-1 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride, USP is a white, odourless, hygroscopic, crystalline powder that is soluble in water and lower alcohols. It is also slightly soluble in chloroform and insoluble in ether. Its structural formula is. Topiramate, USP. Topiramate, USP is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C12H21NO8S and its molecular weight is 339.36.Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Its structural formula is. Phentermine and Topiramate Extended-Release Capsules. Phentermine and topiramate extended-release capsules are for oral administration and available in four dosage strengths:. 3.75 mg/23 mg (phentermine 3.75 mg and topiramate USP, 23 mg) (equivalent to 4.665 mg of Phentermine Hydrochloride, USP). 7.5 mg/46 mg (phentermine 7.5 mg and topiramate USP, 46 mg) (equivalent to 9.33 mg of Phentermine Hydrochloride, USP). 11.25 mg/69 mg (phentermine 11.25 mg and topiramate USP, 69 mg) (equivalent to 14 mg of Phentermine Hydrochloride, USP). 15 mg/92 mg (phentermine 15 mg and topiramate USP, 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride, USP). Each capsule contains the following inactive ingredients: ethocel, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, talc and titanium dioxide. In addition, the 7.5 mg/46 mg contains FD&C Red No. 40 and FD&C Yellow #6, 11.25 mg/69 mg contains FD&C Yellow #5 and FD&C Blue #1, 15 mg/92 mg contains FD&C Yellow #6 and D&C Red #28. The imprinting ink opacode Black contains shellac, iron oxide black, propylene glycol, FD&C Blue #2, FD&C Red No. 40, D&C Yellow #10, FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>43598-626-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (43598-626-30) </PackageDescription>
<NDC11Code>43598-0626-30</NDC11Code>
<ProductNDC>43598-626</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine And Topiramate Extended-release</ProprietaryName>
<NonProprietaryName>Phentermine And Topiramate Extended-release</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208175</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE; TOPIRAMATE</SubstanceName>
<StrengthNumber>11.25; 69</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: 1 Adult patients with obesity, 2 Adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>Phentermine and topiramate extended-release capsules are comprised of immediate-release phentermine hydrochloride, USP (expressed as the weight of the free base) and extended-release topiramate, USP. Phentermine and topiramate extended-release capsules contain phentermine hydrochloride, USP, a sympathomimetic amine anorectic, and topiramate, USP, a sulfamate-substituted monosaccharide. Phentermine Hydrochloride, USP. The chemical name of phentermine hydrochloride, USP is α,α-dimethylphenethylamine hydrochloride. The molecular formula is C10H16ClN and its molecular weight is 185.69 g mol-1 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride, USP is a white, odourless, hygroscopic, crystalline powder that is soluble in water and lower alcohols. It is also slightly soluble in chloroform and insoluble in ether. Its structural formula is. Topiramate, USP. Topiramate, USP is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C12H21NO8S and its molecular weight is 339.36.Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Its structural formula is. Phentermine and Topiramate Extended-Release Capsules. Phentermine and topiramate extended-release capsules are for oral administration and available in four dosage strengths:. 3.75 mg/23 mg (phentermine 3.75 mg and topiramate USP, 23 mg) (equivalent to 4.665 mg of Phentermine Hydrochloride, USP). 7.5 mg/46 mg (phentermine 7.5 mg and topiramate USP, 46 mg) (equivalent to 9.33 mg of Phentermine Hydrochloride, USP). 11.25 mg/69 mg (phentermine 11.25 mg and topiramate USP, 69 mg) (equivalent to 14 mg of Phentermine Hydrochloride, USP). 15 mg/92 mg (phentermine 15 mg and topiramate USP, 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride, USP). Each capsule contains the following inactive ingredients: ethocel, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, talc and titanium dioxide. In addition, the 7.5 mg/46 mg contains FD&C Red No. 40 and FD&C Yellow #6, 11.25 mg/69 mg contains FD&C Yellow #5 and FD&C Blue #1, 15 mg/92 mg contains FD&C Yellow #6 and D&C Red #28. The imprinting ink opacode Black contains shellac, iron oxide black, propylene glycol, FD&C Blue #2, FD&C Red No. 40, D&C Yellow #10, FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>43598-627-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (43598-627-30) </PackageDescription>
<NDC11Code>43598-0627-30</NDC11Code>
<ProductNDC>43598-627</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine And Topiramate Extended-release</ProprietaryName>
<NonProprietaryName>Phentermine And Topiramate Extended-release</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208175</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE; TOPIRAMATE</SubstanceName>
<StrengthNumber>15; 92</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: 1 Adult patients with obesity, 2 Adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>Phentermine and topiramate extended-release capsules are comprised of immediate-release phentermine hydrochloride, USP (expressed as the weight of the free base) and extended-release topiramate, USP. Phentermine and topiramate extended-release capsules contain phentermine hydrochloride, USP, a sympathomimetic amine anorectic, and topiramate, USP, a sulfamate-substituted monosaccharide. Phentermine Hydrochloride, USP. The chemical name of phentermine hydrochloride, USP is α,α-dimethylphenethylamine hydrochloride. The molecular formula is C10H16ClN and its molecular weight is 185.69 g mol-1 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride, USP is a white, odourless, hygroscopic, crystalline powder that is soluble in water and lower alcohols. It is also slightly soluble in chloroform and insoluble in ether. Its structural formula is. Topiramate, USP. Topiramate, USP is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C12H21NO8S and its molecular weight is 339.36.Topiramate, USP is a white to off-white powder. It is freely soluble in dichloromethane. Its structural formula is. Phentermine and Topiramate Extended-Release Capsules. Phentermine and topiramate extended-release capsules are for oral administration and available in four dosage strengths:. 3.75 mg/23 mg (phentermine 3.75 mg and topiramate USP, 23 mg) (equivalent to 4.665 mg of Phentermine Hydrochloride, USP). 7.5 mg/46 mg (phentermine 7.5 mg and topiramate USP, 46 mg) (equivalent to 9.33 mg of Phentermine Hydrochloride, USP). 11.25 mg/69 mg (phentermine 11.25 mg and topiramate USP, 69 mg) (equivalent to 14 mg of Phentermine Hydrochloride, USP). 15 mg/92 mg (phentermine 15 mg and topiramate USP, 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride, USP). Each capsule contains the following inactive ingredients: ethocel, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, talc and titanium dioxide. In addition, the 7.5 mg/46 mg contains FD&C Red No. 40 and FD&C Yellow #6, 11.25 mg/69 mg contains FD&C Yellow #5 and FD&C Blue #1, 15 mg/92 mg contains FD&C Yellow #6 and D&C Red #28. The imprinting ink opacode Black contains shellac, iron oxide black, propylene glycol, FD&C Blue #2, FD&C Red No. 40, D&C Yellow #10, FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>46122-665-15</NDCCode>
<PackageDescription>3 CONTAINER in 1 CARTON (46122-665-15) > 27 LOZENGE in 1 CONTAINER</PackageDescription>
<NDC11Code>46122-0665-15</NDC11Code>
<ProductNDC>46122-665</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy Nicotine Mini</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203690</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51316-666-07</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (51316-666-07) * 236 mL in 1 BOTTLE (51316-665-06) * 236 mL in 1 BOTTLE (51316-664-06) </PackageDescription>
<NDC11Code>51316-0666-07</NDC11Code>
<ProductNDC>51316-666</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime And Nighttime High Blood Pressure Cold And Flu Liquid</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr And Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250421</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55700-665-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (55700-665-30) </PackageDescription>
<NDC11Code>55700-0665-30</NDC11Code>
<ProductNDC>55700-665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204319</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58468-0251-5</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (58468-0251-5) / 28 TABLET, FILM COATED in 1 BLISTER PACK (58468-0251-0) </PackageDescription>
<NDC11Code>58468-0251-05</NDC11Code>
<ProductNDC>58468-0251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Wayrilz</ProprietaryName>
<NonProprietaryName>Rilzabrutinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250829</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219685</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>RILZABRUTINIB</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WAYRILZ is indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.</IndicationAndUsage>
<Description>WAYRILZ (rilzabrutinib) is a kinase inhibitor. Rilzabrutinib is a white to off-white solid, which is freely soluble in ethanol, sparingly soluble in isopropyl alcohol and practically insoluble in water. The chemical name for rilzabrutinib is 1-Piperidinepropanenitrile, 3-[4-amino-3-(2-fluoro-4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-α-[2-methyl-2-[4-(3-oxetanyl)-1-piperazinyl]propylidene]-β-oxo-, (3R)-. The molecular formula is C36H40FN9O3 and the molecular weight is 665.77 Daltons. The chemical structural formula of rilzabrutinib is shown below. Each WAYRILZ film-coated tablet for oral administration contains 400 mg rilzabrutinib. The inactive ingredients in the tablet core are crospovidone (Type A), microcrystalline cellulose, and sodium stearyl fumarate. The inactive ingredients in the tablet coating are FD&C yellow #6/Sunset yellow FCF aluminum lake, macrogol/polyethylene glycol (PEG), polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>60429-665-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (60429-665-01) </PackageDescription>
<NDC11Code>60429-0665-01</NDC11Code>
<ProductNDC>60429-665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091182</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For use as adjunctive therapy in the treatment of peptic ulcer.</IndicationAndUsage>
<Description>Glycopyrrolate tablets contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide. Each glycopyrrolate tablet USP, intended for oral administration, contains glycopyrrolate equivalent to 1 mg or 2 mg. In addition, it also contains the following inactive ingredients: lactose monohydrate, dibasic calcium phosphate anhydrous, povidone, sodium starch glycolate and magnesium stearate. The structural formula of glycopyrrolate is represented below. Molecular Formula: C 19H 28BrNO 3 Molecular Weight: 398.33. Each tablet contains 1 mg or 2 mg of Glycopyrrolate, USP. Inactive Ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>60505-0845-5</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (60505-0845-5) / 240 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>60505-0845-05</NDC11Code>
<ProductNDC>60505-0845</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olopatadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Olopatadine Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20141027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091572</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>OLOPATADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>665</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olopatadine hydrochloride nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.</IndicationAndUsage>
<Description>Olopatadine Hydrochloride Nasal Spray, 665 micrograms (mcg) is a metered-spray for nasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Spray, is a white to off-white, water-soluble crystalline powder. The chemical name for olopatadine hydrochloride is (Z)-11-[3-(dimethylamino)propylidene]-6,11-dihydrodibenz[b,e] oxepin-2-acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3 HCl with the following chemical structure:. Olopatadine Hydrochloride Nasal Spray contains 0.6% w/v olopatadine (base) in a nonsterile aqueous spray with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous spray containing 665 mcg of olopatadine hydrochloride, which is equivalent to 600 mcg of olopatadine (base) [see Dosage Forms and Strengths (3)]. Olopatadine Hydrochloride Nasal Spray also contains anhydrous dibasic sodium phosphate, benzalkonium chloride (0.01%), edetate disodium dihydrate, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water.</Description>
</NDC>
<NDC>
<NDCCode>61010-1112-5</NDCCode>
<PackageDescription>.118 L in 1 BOTTLE (61010-1112-5) </PackageDescription>
<NDC11Code>61010-1112-05</NDC11Code>
<ProductNDC>61010-1112</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120322</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Safetec of America, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>665</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on skin without soap and water. recommended for repeated use.</IndicationAndUsage>
</NDC>
</NDCList>