{
"NDC": [
{
"NDCCode": "70756-055-12",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (70756-055-12) ",
"NDC11Code": "70756-0055-12",
"ProductNDC": "70756-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvstatin",
"NonProprietaryName": "Rosuvstatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206603",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260816",
"SamplePackage": "N"
},
{
"NDCCode": "70756-055-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70756-055-90) ",
"NDC11Code": "70756-0055-90",
"ProductNDC": "70756-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvstatin",
"NonProprietaryName": "Rosuvstatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206603",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260816",
"SamplePackage": "N"
},
{
"NDCCode": "17518-055-01",
"PackageDescription": "12 BOTTLE, PUMP in 1 CASE (17518-055-01) / 500 mL in 1 BOTTLE, PUMP",
"NDC11Code": "17518-0055-01",
"ProductNDC": "17518-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "3m Avagard Foaming Instant Hand Antiseptic",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110527",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Solventum US LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "548",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110527",
"SamplePackage": "N",
"IndicationAndUsage": "instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease : 1 instant hand antiseptic to decrease bacteria on the skin , 2 recommended for repeated use ."
},
{
"NDCCode": "33342-055-12",
"PackageDescription": "100 TABLET in 1 BOX, UNIT-DOSE (33342-055-12) ",
"NDC11Code": "33342-0055-12",
"ProductNDC": "33342-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202467",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130214",
"SamplePackage": "N",
"IndicationAndUsage": "Monotherapy and Combination Therapy Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14) ]. Important Limitations of Use Pioglitazone tablets, USP exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets USP should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3) ].",
"Description": "Pioglitazone tablets USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride, USP is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone hydrochloride USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropylcellulose, carboxymethylcellulose calcium, and magnesium stearate."
},
{
"NDCCode": "41163-055-12",
"PackageDescription": "1500 mL in 1 BOTTLE, PLASTIC (41163-055-12) ",
"NDC11Code": "41163-0055-12",
"ProductNDC": "41163-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antispetic",
"NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "19940729",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "United Natural Foods, Inc. dba UNFI",
"SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".92; .42; .6; .64",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19940729",
"SamplePackage": "N",
"IndicationAndUsage": "helps control plaque that leads to gingivitis."
},
{
"NDCCode": "42291-055-12",
"PackageDescription": "1 BOTTLE, PUMP in 1 BOX (42291-055-12) / 112 g in 1 BOTTLE, PUMP",
"NDC11Code": "42291-0055-12",
"ProductNDC": "42291-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212506",
"LabelerName": "AvKARE",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230829",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).",
"Description": "Diclofenac sodium topical solution USP, 2% w/w, contains diclofenac sodium, USP a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug, and is available as a clear, colorless to faintly pink or orange solution for topical application. The chemical name is 2 [(2,6-dichlorophenyl) amino]-benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2,and it has the following chemical structure. Each 1 gram of solution contains 20 mg of diclofenac sodium, USP. The inactive ingredients: dimethyl sulfoxide USP (DMSO, 45.5% w/w), ethanol (31.3% v/v), purified water, propylene glycol, and hydroxypropyl cellulose."
},
{
"NDCCode": "49781-055-12",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (49781-055-12) > 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "49781-0055-12",
"ProductNDC": "49781-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Day Time",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131121",
"EndMarketingDate": "20190111",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Cardinal Health",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131121",
"EndMarketingDatePackage": "20190111",
"SamplePackage": "N"
},
{
"NDCCode": "51655-055-27",
"PackageDescription": "12 TABLET in 1 BOTTLE, DISPENSING (51655-055-27)",
"NDC11Code": "51655-0055-27",
"ProductNDC": "51655-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040656",
"LabelerName": "Northwind Pharmaceuticals, LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-01-01",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.",
"Description": "Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg. Each tablet contains. Hydrocodone Bitartrate ............. 7.5 mgAcetaminophen ......................... 325 mg. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Red #40 aluminum lake, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "52959-055-12",
"PackageDescription": "12 CAPSULE in 1 BOTTLE, PLASTIC (52959-055-12)",
"NDC11Code": "52959-0055-12",
"ProductNDC": "52959-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19841107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062396",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The structural formula is as follows. with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. Doxycycline is a light yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate. 100 mg gelatin capsule shell contains: FD&C Blue #1, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The printing ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, n-Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A Alcohol and Synthetic Black Iron Oxide."
},
{
"NDCCode": "59321-055-05",
"PackageDescription": "12 mL in 1 BOTTLE (59321-055-05) ",
"NDC11Code": "59321-0055-05",
"ProductNDC": "59321-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zheng Gu Shui",
"NonProprietaryName": "Camphor, Menthol",
"DosageFormName": "LINIMENT",
"RouteName": "PERCUTANEOUS; TRANSDERMAL",
"StartMarketingDate": "20250601",
"EndMarketingDate": "20300601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL",
"StrengthNumber": "5.6; 5.6",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250601",
"EndMarketingDatePackage": "20300601",
"SamplePackage": "Y",
"IndicationAndUsage": "Uses For the temporary relief of minor aches and pains of muscles and joints due to: ■ arthritis ■ strains ■ bruises ■ sprains ■ simple backache."
},
{
"NDCCode": "61715-055-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (61715-055-24) > 12 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "61715-0055-24",
"ProductNDC": "61715-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Preferred Plus Complete Allergy Medicine",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130507",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kinray Inc.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "68828-055-12",
"PackageDescription": "1 JAR in 1 BOX (68828-055-12) > 50 mL in 1 JAR (68828-055-62)",
"NDC11Code": "68828-0055-12",
"ProductNDC": "68828-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calming Dynamics",
"ProprietaryNameSuffix": "Spf 15",
"NonProprietaryName": "Octinoxate Octisalate Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120424",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "JAFRA COSMETICS INTERNATIONAL",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE",
"StrengthNumber": "7; 4; 2",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "GENTLE HYDRATING DAY CREAM SPF 15."
},
{
"NDCCode": "69301-055-12",
"PackageDescription": "125 g in 1 BOTTLE, PUMP (69301-055-12)",
"NDC11Code": "69301-0055-12",
"ProductNDC": "69301-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Top Quality Mfg Apf",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "DENTAL",
"StartMarketingDate": "20140501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Top Quality Manufacturing, Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5375",
"StrengthUnit": "g/125g",
"Status": "Deprecated",
"LastUpdate": "2019-02-09",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "70377-055-12",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-12) ",
"NDC11Code": "70377-0055-12",
"ProductNDC": "70377-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213486",
"LabelerName": "Biocon Pharma Inc.,",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210319",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole is a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: : 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 3 H2O with molecular weight of 767.17 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored powder. It contains 3 moles of water of solvation and is slightly soluble in methanol, insoluble in water and in n-Heptane. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium delayed-release capsules are supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (equivalent as 22.25 mg, or 44.50 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono-and di-glycerides, polysorbate 80, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink also contains ferric oxide black, shellac, strong ammonium solution, potassium hydroxide and propylene glycol."
},
{
"NDCCode": "71930-055-12",
"PackageDescription": "100 TABLET in 1 BOTTLE (71930-055-12) ",
"NDC11Code": "71930-0055-12",
"ProductNDC": "71930-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211610",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190802",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, (see WARNINGS), reserve opioid analgesics, including codeine phosphate for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:. C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only)."
},
{
"NDCCode": "76168-055-02",
"PackageDescription": "12 CARTON in 1 BLISTER PACK (76168-055-02) > 1 CAPSULE, LIQUID FILLED in 1 CARTON",
"NDC11Code": "76168-0055-02",
"ProductNDC": "76168-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Cold And Flu",
"NonProprietaryName": "Acetaminophen,dextromethorphan,phenylephrine",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20140501",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Velocity Pharma",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "pain reliever, cough suppressant and Nasal decongestant."
},
{
"NDCCode": "76420-055-12",
"PackageDescription": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-055-12) ",
"NDC11Code": "76420-0055-12",
"ProductNDC": "76420-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091672",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250121",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the:. Treatment of active duodenal ulcer in adults ( 1.1) . Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) . Treatment of active benign gastric ulcer in adults ( 1.3) . Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) . Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) . Pathologic hypersecretory conditions in adults ( 1.7) .",
"Description": "The active ingredient in Omeprazole Delayed-Release Capsules, USP is a substituted benzimidazole, 5-methoxy-2[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 17H 19N 3O 3S, with a molecular weight of 345.42 g/mol. The structural formula is:. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole, USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole, USP in the form of enteric-coated granules with the following inactive ingredients: anhydrous lactose, cetyl alcohol, di-sodium hydrogen phosphate dihydrate, hypromellose, hypromellose phthalate, mannitol, simethicone emulsion 30%, sodium lauryl sulfate and sugar sphere. The capsule shell for Omeprazole Delayed-Release Capsules, USP 10 mg contains D&C Yellow No.10, FD&C Blue No.1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for Omeprazole Delayed-Release Capsules, USP 20 mg contains FD&C Blue No.1, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for Omeprazole Delayed-Release Capsules, USP 40 mg contains D&C Yellow No.10, FD&C Blue No.1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink has the following components: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution and shellac."
},
{
"NDCCode": "84660-055-01",
"PackageDescription": "12 g in 1 BOX (84660-055-01) ",
"NDC11Code": "84660-0055-01",
"ProductNDC": "84660-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jaysuing Wart Removers",
"NonProprietaryName": "Glycerin",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241031",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M014",
"LabelerName": "Guangdong�Ximonth�Technology�Co.,�Ltd.",
"SubstanceName": "ARGAN OIL; CALENDULA OFFICINALIS FLOWER; TEA TREE OIL",
"StrengthNumber": "2; 4; 2",
"StrengthUnit": "g/12g; g/12g; g/12g",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241031",
"SamplePackage": "N"
},
{
"NDCCode": "70756-001-12",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70756-001-12) ",
"NDC11Code": "70756-0001-12",
"ProductNDC": "70756-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216918",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240411",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "70756-002-12",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70756-002-12) ",
"NDC11Code": "70756-0002-12",
"ProductNDC": "70756-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216918",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240411",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "70756-003-12",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70756-003-12) ",
"NDC11Code": "70756-0003-12",
"ProductNDC": "70756-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216918",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240411",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "70756-004-12",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70756-004-12) ",
"NDC11Code": "70756-0004-12",
"ProductNDC": "70756-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216918",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240411",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "70756-006-12",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70756-006-12) ",
"NDC11Code": "70756-0006-12",
"ProductNDC": "70756-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220874",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8).",
"Description": "Rivaroxaban, USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban, USP is sparingly soluble in dimethyl formamide and practically insoluble in water. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: croscarmellose sodium, hydroxy propyl methyl cellulose, magnesium stearate, microcrystalline cellulose (PH 101), microcrystalline cellulose (PH 102), lactose monohydrate, sodium lauryl sulphate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets, USP 2.5 mg is Opadry Yellow containing hypromellose, titanium dioxide, polyethylene glycol 3350, iron oxide yellow. FDA-approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70756-011-12",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70756-011-12) ",
"NDC11Code": "70756-0011-12",
"ProductNDC": "70756-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorthalidone",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215587",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "CHLORTHALIDONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220805",
"SamplePackage": "N",
"IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
"Description": "Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1- hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate Type A, stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "70756-019-12",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70756-019-12) ",
"NDC11Code": "70756-0019-12",
"ProductNDC": "70756-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium Delayed-release",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215880",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220727",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.37. The structural formula is. Pantoprazole sodium is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, in methanol, and in dehydrated alcohol; practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole Sodium Delayed-Release Tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, hypromellose, ferric oxide red, ferrosoferric oxide black, mannitol, methacrylic acid- ethyl acrylate copolymer, polyethylene glycol, silicon dioxide, sodium carbonate, sucrose, talc, and triethyl citrate. Imprinting ink contains ammonium hydroxide, ferrosoferric oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze. Meets USP Dissolution Test 3."
},
{
"NDCCode": "70756-020-12",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70756-020-12) ",
"NDC11Code": "70756-0020-12",
"ProductNDC": "70756-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorthalidone",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215587",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "CHLORTHALIDONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220805",
"SamplePackage": "N",
"IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
"Description": "Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1- hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate Type A, stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "70756-051-12",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70756-051-12) ",
"NDC11Code": "70756-0051-12",
"ProductNDC": "70756-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075302",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231019",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidinetablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.",
"Description": "The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. Famotidine, USP is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate."
},
{
"NDCCode": "70756-052-12",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70756-052-12) ",
"NDC11Code": "70756-0052-12",
"ProductNDC": "70756-052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075302",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231019",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidinetablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.",
"Description": "The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. Famotidine, USP is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate."
},
{
"NDCCode": "70756-053-12",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (70756-053-12) ",
"NDC11Code": "70756-0053-12",
"ProductNDC": "70756-053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvstatin",
"NonProprietaryName": "Rosuvstatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206603",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260816",
"SamplePackage": "N"
},
{
"NDCCode": "70756-054-12",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (70756-054-12) ",
"NDC11Code": "70756-0054-12",
"ProductNDC": "70756-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvstatin",
"NonProprietaryName": "Rosuvstatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206603",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260816",
"SamplePackage": "N"
}
]
}
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<NDC>
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<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (70756-055-12) </PackageDescription>
<NDC11Code>70756-0055-12</NDC11Code>
<ProductNDC>70756-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvstatin</ProprietaryName>
<NonProprietaryName>Rosuvstatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206603</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70756-055-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70756-055-90) </PackageDescription>
<NDC11Code>70756-0055-90</NDC11Code>
<ProductNDC>70756-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvstatin</ProprietaryName>
<NonProprietaryName>Rosuvstatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206603</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17518-055-01</NDCCode>
<PackageDescription>12 BOTTLE, PUMP in 1 CASE (17518-055-01) / 500 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>17518-0055-01</NDC11Code>
<ProductNDC>17518-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>3m Avagard Foaming Instant Hand Antiseptic</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Solventum US LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>548</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease : 1 instant hand antiseptic to decrease bacteria on the skin , 2 recommended for repeated use .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33342-055-12</NDCCode>
<PackageDescription>100 TABLET in 1 BOX, UNIT-DOSE (33342-055-12) </PackageDescription>
<NDC11Code>33342-0055-12</NDC11Code>
<ProductNDC>33342-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202467</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Monotherapy and Combination Therapy Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14) ]. Important Limitations of Use Pioglitazone tablets, USP exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets USP should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3) ].</IndicationAndUsage>
<Description>Pioglitazone tablets USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride, USP is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone hydrochloride USP is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate, hydroxypropylcellulose, carboxymethylcellulose calcium, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>41163-055-12</NDCCode>
<PackageDescription>1500 mL in 1 BOTTLE, PLASTIC (41163-055-12) </PackageDescription>
<NDC11Code>41163-0055-12</NDC11Code>
<ProductNDC>41163-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antispetic</ProprietaryName>
<NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940729</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>United Natural Foods, Inc. dba UNFI</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.92; .42; .6; .64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps control plaque that leads to gingivitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42291-055-12</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 BOX (42291-055-12) / 112 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>42291-0055-12</NDC11Code>
<ProductNDC>42291-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212506</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).</IndicationAndUsage>
<Description>Diclofenac sodium topical solution USP, 2% w/w, contains diclofenac sodium, USP a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug, and is available as a clear, colorless to faintly pink or orange solution for topical application. The chemical name is 2 [(2,6-dichlorophenyl) amino]-benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2,and it has the following chemical structure. Each 1 gram of solution contains 20 mg of diclofenac sodium, USP. The inactive ingredients: dimethyl sulfoxide USP (DMSO, 45.5% w/w), ethanol (31.3% v/v), purified water, propylene glycol, and hydroxypropyl cellulose.</Description>
</NDC>
<NDC>
<NDCCode>49781-055-12</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (49781-055-12) > 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49781-0055-12</NDC11Code>
<ProductNDC>49781-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Day Time</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131121</StartMarketingDate>
<EndMarketingDate>20190111</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131121</StartMarketingDatePackage>
<EndMarketingDatePackage>20190111</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51655-055-27</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE, DISPENSING (51655-055-27)</PackageDescription>
<NDC11Code>51655-0055-27</NDC11Code>
<ProductNDC>51655-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040656</ApplicationNumber>
<LabelerName>Northwind Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-01-01</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg. Each tablet contains. Hydrocodone Bitartrate ............. 7.5 mgAcetaminophen ......................... 325 mg. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Red #40 aluminum lake, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>52959-055-12</NDCCode>
<PackageDescription>12 CAPSULE in 1 BOTTLE, PLASTIC (52959-055-12)</PackageDescription>
<NDC11Code>52959-0055-12</NDC11Code>
<ProductNDC>52959-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19841107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062396</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The structural formula is as follows. with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. Doxycycline is a light yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate. 100 mg gelatin capsule shell contains: FD&C Blue #1, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The printing ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, n-Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A Alcohol and Synthetic Black Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>59321-055-05</NDCCode>
<PackageDescription>12 mL in 1 BOTTLE (59321-055-05) </PackageDescription>
<NDC11Code>59321-0055-05</NDC11Code>
<ProductNDC>59321-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zheng Gu Shui</ProprietaryName>
<NonProprietaryName>Camphor, Menthol</NonProprietaryName>
<DosageFormName>LINIMENT</DosageFormName>
<RouteName>PERCUTANEOUS; TRANSDERMAL</RouteName>
<StartMarketingDate>20250601</StartMarketingDate>
<EndMarketingDate>20300601</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL</SubstanceName>
<StrengthNumber>5.6; 5.6</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<EndMarketingDatePackage>20300601</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Uses For the temporary relief of minor aches and pains of muscles and joints due to: ■ arthritis ■ strains ■ bruises ■ sprains ■ simple backache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61715-055-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (61715-055-24) > 12 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>61715-0055-24</NDC11Code>
<ProductNDC>61715-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Preferred Plus Complete Allergy Medicine</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130507</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kinray Inc.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68828-055-12</NDCCode>
<PackageDescription>1 JAR in 1 BOX (68828-055-12) > 50 mL in 1 JAR (68828-055-62)</PackageDescription>
<NDC11Code>68828-0055-12</NDC11Code>
<ProductNDC>68828-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calming Dynamics</ProprietaryName>
<ProprietaryNameSuffix>Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate Octisalate Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120424</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>JAFRA COSMETICS INTERNATIONAL</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
<StrengthNumber>7; 4; 2</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>GENTLE HYDRATING DAY CREAM SPF 15.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69301-055-12</NDCCode>
<PackageDescription>125 g in 1 BOTTLE, PUMP (69301-055-12)</PackageDescription>
<NDC11Code>69301-0055-12</NDC11Code>
<ProductNDC>69301-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Top Quality Mfg Apf</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20140501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Top Quality Manufacturing, Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.5375</StrengthNumber>
<StrengthUnit>g/125g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-09</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70377-055-12</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-12) </PackageDescription>
<NDC11Code>70377-0055-12</NDC11Code>
<ProductNDC>70377-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213486</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.,</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole is a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: : 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 3 H2O with molecular weight of 767.17 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored powder. It contains 3 moles of water of solvation and is slightly soluble in methanol, insoluble in water and in n-Heptane. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium delayed-release capsules are supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (equivalent as 22.25 mg, or 44.50 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono-and di-glycerides, polysorbate 80, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink also contains ferric oxide black, shellac, strong ammonium solution, potassium hydroxide and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>71930-055-12</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71930-055-12) </PackageDescription>
<NDC11Code>71930-0055-12</NDC11Code>
<ProductNDC>71930-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211610</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, (see WARNINGS), reserve opioid analgesics, including codeine phosphate for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Acetaminophen and Codeine Phosphate Tablets, USP are supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:. C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3 H3PO4 ½H2O M.W. 406.37 Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/15 mg contains: Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/30 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg Each Acetaminophen and Codeine Phosphate Tablet USP, 300 mg/60 mg contains: Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, FD&C Red #40 aluminum lake (300 mg/15 mg only), and FD&C Blue#1 aluminum lake (300 mg/60 mg only).</Description>
</NDC>
<NDC>
<NDCCode>76168-055-02</NDCCode>
<PackageDescription>12 CARTON in 1 BLISTER PACK (76168-055-02) > 1 CAPSULE, LIQUID FILLED in 1 CARTON</PackageDescription>
<NDC11Code>76168-0055-02</NDC11Code>
<ProductNDC>76168-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen,dextromethorphan,phenylephrine</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Velocity Pharma</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>pain reliever, cough suppressant and Nasal decongestant.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76420-055-12</NDCCode>
<PackageDescription>120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-055-12) </PackageDescription>
<NDC11Code>76420-0055-12</NDC11Code>
<ProductNDC>76420-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091672</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the:. Treatment of active duodenal ulcer in adults ( 1.1) . Eradication of Helicobacter pylorito reduce the risk of duodenal ulcer recurrence in adults ( 1.2) . Treatment of active benign gastric ulcer in adults ( 1.3) . Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4) . Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6) . Pathologic hypersecretory conditions in adults ( 1.7) .</IndicationAndUsage>
<Description>The active ingredient in Omeprazole Delayed-Release Capsules, USP is a substituted benzimidazole, 5-methoxy-2[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 17H 19N 3O 3S, with a molecular weight of 345.42 g/mol. The structural formula is:. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole, USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole, USP in the form of enteric-coated granules with the following inactive ingredients: anhydrous lactose, cetyl alcohol, di-sodium hydrogen phosphate dihydrate, hypromellose, hypromellose phthalate, mannitol, simethicone emulsion 30%, sodium lauryl sulfate and sugar sphere. The capsule shell for Omeprazole Delayed-Release Capsules, USP 10 mg contains D&C Yellow No.10, FD&C Blue No.1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for Omeprazole Delayed-Release Capsules, USP 20 mg contains FD&C Blue No.1, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for Omeprazole Delayed-Release Capsules, USP 40 mg contains D&C Yellow No.10, FD&C Blue No.1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink has the following components: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, strong ammonia solution and shellac.</Description>
</NDC>
<NDC>
<NDCCode>84660-055-01</NDCCode>
<PackageDescription>12 g in 1 BOX (84660-055-01) </PackageDescription>
<NDC11Code>84660-0055-01</NDC11Code>
<ProductNDC>84660-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Jaysuing Wart Removers</ProprietaryName>
<NonProprietaryName>Glycerin</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241031</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M014</ApplicationNumber>
<LabelerName>Guangdong�Ximonth�Technology�Co.,�Ltd.</LabelerName>
<SubstanceName>ARGAN OIL; CALENDULA OFFICINALIS FLOWER; TEA TREE OIL</SubstanceName>
<StrengthNumber>2; 4; 2</StrengthNumber>
<StrengthUnit>g/12g; g/12g; g/12g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70756-001-12</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70756-001-12) </PackageDescription>
<NDC11Code>70756-0001-12</NDC11Code>
<ProductNDC>70756-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216918</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>70756-002-12</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70756-002-12) </PackageDescription>
<NDC11Code>70756-0002-12</NDC11Code>
<ProductNDC>70756-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216918</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>70756-003-12</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70756-003-12) </PackageDescription>
<NDC11Code>70756-0003-12</NDC11Code>
<ProductNDC>70756-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216918</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>70756-004-12</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70756-004-12) </PackageDescription>
<NDC11Code>70756-0004-12</NDC11Code>
<ProductNDC>70756-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216918</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>70756-006-12</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70756-006-12) </PackageDescription>
<NDC11Code>70756-0006-12</NDC11Code>
<ProductNDC>70756-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220874</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8).</IndicationAndUsage>
<Description>Rivaroxaban, USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban, USP is sparingly soluble in dimethyl formamide and practically insoluble in water. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: croscarmellose sodium, hydroxy propyl methyl cellulose, magnesium stearate, microcrystalline cellulose (PH 101), microcrystalline cellulose (PH 102), lactose monohydrate, sodium lauryl sulphate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets, USP 2.5 mg is Opadry Yellow containing hypromellose, titanium dioxide, polyethylene glycol 3350, iron oxide yellow. FDA-approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70756-011-12</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70756-011-12) </PackageDescription>
<NDC11Code>70756-0011-12</NDC11Code>
<ProductNDC>70756-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorthalidone</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215587</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
<Description>Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1- hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate Type A, stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70756-019-12</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70756-019-12) </PackageDescription>
<NDC11Code>70756-0019-12</NDC11Code>
<ProductNDC>70756-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium Delayed-release</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium Delayed-release</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215880</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.37. The structural formula is. Pantoprazole sodium is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, in methanol, and in dehydrated alcohol; practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole Sodium Delayed-Release Tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, hypromellose, ferric oxide red, ferrosoferric oxide black, mannitol, methacrylic acid- ethyl acrylate copolymer, polyethylene glycol, silicon dioxide, sodium carbonate, sucrose, talc, and triethyl citrate. Imprinting ink contains ammonium hydroxide, ferrosoferric oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>70756-020-12</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70756-020-12) </PackageDescription>
<NDC11Code>70756-0020-12</NDC11Code>
<ProductNDC>70756-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorthalidone</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215587</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
<Description>Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1- hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate Type A, stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70756-051-12</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70756-051-12) </PackageDescription>
<NDC11Code>70756-0051-12</NDC11Code>
<ProductNDC>70756-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075302</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidinetablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. Famotidine, USP is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>70756-052-12</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70756-052-12) </PackageDescription>
<NDC11Code>70756-0052-12</NDC11Code>
<ProductNDC>70756-052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075302</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidinetablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. Famotidine, USP is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>70756-053-12</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (70756-053-12) </PackageDescription>
<NDC11Code>70756-0053-12</NDC11Code>
<ProductNDC>70756-053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvstatin</ProprietaryName>
<NonProprietaryName>Rosuvstatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206603</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70756-054-12</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (70756-054-12) </PackageDescription>
<NDC11Code>70756-0054-12</NDC11Code>
<ProductNDC>70756-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvstatin</ProprietaryName>
<NonProprietaryName>Rosuvstatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206603</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>