{
"NDC": [
{
"NDCCode": "70512-865-15",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70512-865-15) / 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "70512-0865-15",
"ProductNDC": "70512-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215183",
"LabelerName": "SOLA Pharmaceuticals, LLC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240601",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.",
"Description": "Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless, topical - adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy- [(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C 9H 13NO 2.HCl Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%)."
},
{
"NDCCode": "70512-865-02",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70512-865-02) / 2 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "70512-0865-02",
"ProductNDC": "70512-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215183",
"LabelerName": "SOLA Pharmaceuticals, LLC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240601",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.",
"Description": "Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless, topical - adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy- [(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C 9H 13NO 2.HCl Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%)."
},
{
"NDCCode": "70512-011-15",
"PackageDescription": "3 POUCH in 1 BOX (70512-011-15) > 1 g in 1 POUCH",
"NDC11Code": "70512-0011-15",
"ProductNDC": "70512-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lenza Pro",
"NonProprietaryName": "Lidocaine/menthol Patch",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180208",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Sola Pharmaceuticals",
"SubstanceName": "LIDOCAINE; MENTHOL",
"StrengthNumber": "40; 40",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180208",
"SamplePackage": "N"
},
{
"NDCCode": "70512-013-15",
"PackageDescription": "3 POUCH in 1 BOX (70512-013-15) / 1 g in 1 POUCH",
"NDC11Code": "70512-0013-15",
"ProductNDC": "70512-013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lenzapro Flex",
"NonProprietaryName": "Lidocaine/menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "SOLA Pharmaceuticals",
"SubstanceName": "MENTHOL; LIDOCAINE",
"StrengthNumber": "40; 40",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For the temporary relief of pain."
},
{
"NDCCode": "70512-015-15",
"PackageDescription": "3 POUCH in 1 BOX (70512-015-15) / 5 g in 1 POUCH",
"NDC11Code": "70512-0015-15",
"ProductNDC": "70512-015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Synoflex Patch",
"NonProprietaryName": "Synoflex Patch",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220428",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Sola Pharmaceuticals",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; MENTHOL",
"StrengthNumber": "40; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220428",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain."
},
{
"NDCCode": "70512-017-15",
"PackageDescription": "3 POUCH in 1 BOX (70512-017-15) / 5 g in 1 POUCH",
"NDC11Code": "70512-0017-15",
"ProductNDC": "70512-017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triceptin",
"NonProprietaryName": "Lidocaine / Menthol / Methyl Salicylate",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221205",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "SOLA Pharmaceuticals",
"SubstanceName": "LIDOCAINE; METHYL SALICYLATE; MENTHOL",
"StrengthNumber": "40; 20; 10",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221205",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: 1 Muscle soreness, 2 strains, 3 sprains, 4 arthritis, 5 simple backache, 6 muscle stiffness, 7 bruises."
},
{
"NDCCode": "70512-020-15",
"PackageDescription": "1 TUBE in 1 CARTON (70512-020-15) > 15 g in 1 TUBE",
"NDC11Code": "70512-0020-15",
"ProductNDC": "70512-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate Oint 0.05%",
"NonProprietaryName": "Clobetasol Propionate Oint 0.05%",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208589",
"LabelerName": "Sola Pharmaceuticals",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200218",
"SamplePackage": "N"
},
{
"NDCCode": "70512-028-15",
"PackageDescription": "1 TUBE in 1 CARTON (70512-028-15) > 15 g in 1 TUBE",
"NDC11Code": "70512-0028-15",
"ProductNDC": "70512-028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate Cream",
"NonProprietaryName": "Clobetasol Propionate Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209974",
"LabelerName": "Sola Pharmaceuticals",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200217",
"SamplePackage": "N"
},
{
"NDCCode": "70512-100-15",
"PackageDescription": "1 TUBE in 1 CARTON (70512-100-15) > 14.2 g in 1 TUBE",
"NDC11Code": "70512-0100-15",
"ProductNDC": "70512-100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clotrimazole Cream 1%",
"NonProprietaryName": "Clotrimazole Cream 1%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200414",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "SOLA Pharmaceuticals",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20211021",
"SamplePackage": "N",
"IndicationAndUsage": "For External treatment of most athlete's foot (tinea pedis), jock ithc (tinea crusis), ringworm (tinea corporis). Relieves itching, cracking scaling irritation and chafing associated with these conditions."
},
{
"NDCCode": "14593-865-02",
"PackageDescription": "15 kg in 1 DRUM (14593-865-02) ",
"NDC11Code": "14593-0865-02",
"ProductNDC": "14593-865",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Busulfan",
"DosageFormName": "POWDER",
"StartMarketingDate": "20231225",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Emcure Pharmaceuticals Limited",
"SubstanceName": "BUSULFAN",
"StrengthNumber": "5",
"StrengthUnit": "kg/5kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-27",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "25-DEC-23"
},
{
"NDCCode": "35356-865-15",
"PackageDescription": "15 CAPSULE in 1 BOTTLE (35356-865-15)",
"NDC11Code": "35356-0865-15",
"ProductNDC": "35356-865",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diphenhydramine Hydrochloride",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20000501",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "41520-865-05",
"PackageDescription": "1 BOTTLE in 1 BOX (41520-865-05) > 15 mL in 1 BOTTLE",
"NDC11Code": "41520-0865-05",
"ProductNDC": "41520-865",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Artificial Tears",
"NonProprietaryName": "Glycerin, Hypromellose, Polyethylene Glycol 400",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20100906",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "American Sales Company",
"SubstanceName": "GLYCERIN; POLYETHYLENE GLYCOL 400; HYPROMELLOSES",
"StrengthNumber": "2; 10; 2",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100910",
"SamplePackage": "N"
},
{
"NDCCode": "64762-865-15",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (64762-865-15) > 15 mL in 1 BOTTLE, PUMP",
"NDC11Code": "64762-0865-15",
"ProductNDC": "64762-865",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oxymetazoline Hydrochloride",
"NonProprietaryName": "Oxymetazoline Hydrochloride",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20091104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dynamic Pharmaceuticals",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/.4mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Temporarily relieves nasal congestion due to: 1 common cold, 2 hay fever, 3 upper respiratory allergies, 4 helps clear nasal passages, 5 shrinks swollen membranes, 6 temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "71610-865-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (71610-865-15) ",
"NDC11Code": "71610-0865-15",
"ProductNDC": "71610-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075977",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241118",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride, USP is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride. Its structural formula is:. C 16H 25NO 2HCl M.W. 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP (equivalent to 43.9 mg of tramadol) and are white in color. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 4000, pregelatinized corn starch, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "76420-865-15",
"PackageDescription": "150 TABLET in 1 BOTTLE (76420-865-15) ",
"NDC11Code": "76420-0865-15",
"ProductNDC": "76420-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076286",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241029",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine tablet is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1) ].",
"Description": "Tizanidine hydrochloride USP, is a central α 2-adrenergic agonist. Tizanidine hydrochloride USP is almost white to slightly yellow crystalline powder, which is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole monohydrochloride. Tizanidine’s molecular formula is C 9H 8ClN 5S.HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine tablets USP, are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets USP, contain the active ingredient, tizanidine hydrochloride USP (2.288 mg equivalent to 2 mg tizanidine base and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, microcrystalline cellulose, colloidal silicon dioxide and stearic acid."
},
{
"NDCCode": "84756-865-02",
"PackageDescription": "15 g in 1 BOX (84756-865-02) ",
"NDC11Code": "84756-0865-02",
"ProductNDC": "84756-865",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lift Firm Booty Mask",
"NonProprietaryName": "Lift Firm Booty Mask",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "70512-842-25",
"PackageDescription": "25 VIAL in 1 CARTON (70512-842-25) / 1 mL in 1 VIAL (70512-842-01) ",
"NDC11Code": "70512-0842-25",
"ProductNDC": "70512-842",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217789",
"LabelerName": "SOLA Pharmaceuticals, LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients. Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS).Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.",
"Description": "Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1 H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) of ketorolac tromethamine in sterile solution. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, and 4.35 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color."
},
{
"NDCCode": "70512-843-25",
"PackageDescription": "25 VIAL in 1 CARTON (70512-843-25) / 1 mL in 1 VIAL (70512-843-01) ",
"NDC11Code": "70512-0843-25",
"ProductNDC": "70512-843",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217789",
"LabelerName": "SOLA Pharmaceuticals, LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients. Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS).Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.",
"Description": "Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1 H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) of ketorolac tromethamine in sterile solution. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, and 4.35 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color."
},
{
"NDCCode": "70512-844-25",
"PackageDescription": "25 VIAL in 1 CARTON (70512-844-25) / 2 mL in 1 VIAL (70512-844-01) ",
"NDC11Code": "70512-0844-25",
"ProductNDC": "70512-844",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20241022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217789",
"LabelerName": "SOLA Pharmaceuticals, LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241022",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients. Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS).Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.",
"Description": "Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1 H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) of ketorolac tromethamine in sterile solution. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, and 4.35 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color."
},
{
"NDCCode": "70512-859-05",
"PackageDescription": "5 VIAL, SINGLE-DOSE in 1 CARTON (70512-859-05) / 1 mL in 1 VIAL, SINGLE-DOSE (70512-859-01) ",
"NDC11Code": "70512-0859-05",
"ProductNDC": "70512-859",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboprost Tromethamine",
"NonProprietaryName": "Carboprost Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20230925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216824",
"LabelerName": "SOLA Pharmaceuticals, LLC",
"SubstanceName": "CARBOPROST TROMETHAMINE",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230925",
"SamplePackage": "N",
"IndicationAndUsage": "Carboprost tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1 Failure of expulsion of the fetus during the course of treatment by another method; , 2 Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; , 3 Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; , 4 Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.",
"Description": "Carboprost tromethamine injection, USP, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in carboprost tromethamine injection, USP. Four other chemical names are: : 1 (15S)-15-methyl prostaglandin F2α tromethamine salt , 2 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α-cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol , 3 (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt , 4 (15S)-15-methyl PGF2α-THAM ."
},
{
"NDCCode": "25208-201-15",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (25208-201-15) ",
"NDC11Code": "25208-0201-15",
"ProductNDC": "25208-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zypitamag",
"NonProprietaryName": "Pitavastatin Magnesium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208379",
"LabelerName": "Medicure International Inc",
"SubstanceName": "PITAVASTATIN",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180309",
"SamplePackage": "N",
"IndicationAndUsage": "ZYPITAMAG is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Pediatric use information is approved for Kowa Co Ltd LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "ZYPITAMAG (pitavastatin) tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (3R,5S)-7-[2-Cyclopropyl-4-(4-fluorophenyl) quinoline-3-yl]3,5-dihydroxy-6(E)-heptanoic acid hemi magnesium. The structural formula is. The molecular formula for pitavastatin is C50H46MgF2N2O8 and the molecular weight is 865.21. Pitavastatin is a white to off-white powder. It is freely soluble in acetone, ethyl acetate; soluble in dimethylsulfoxide and insoluble in dichloromethane and isopropyl alcohol. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of ZYPITAMAG contains 2.053 mg or 4.106 mg of pitavastatin magnesium, which is equivalent to 2 mg or 4 mg, respectively of free base and the following inactive ingredients: calcium carbonate, crospovidone, hypromellose, lactose monohydrate, magnesium stearate and sodium carbonate anhydrous and film-coating containing the following inactive ingredients: hypromellose, polyethylene glycol, talc and titanium dioxide."
},
{
"NDCCode": "25208-202-15",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (25208-202-15) ",
"NDC11Code": "25208-0202-15",
"ProductNDC": "25208-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zypitamag",
"NonProprietaryName": "Pitavastatin Magnesium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208379",
"LabelerName": "Medicure International Inc",
"SubstanceName": "PITAVASTATIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180309",
"SamplePackage": "N",
"IndicationAndUsage": "ZYPITAMAG is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Pediatric use information is approved for Kowa Co Ltd LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "ZYPITAMAG (pitavastatin) tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (3R,5S)-7-[2-Cyclopropyl-4-(4-fluorophenyl) quinoline-3-yl]3,5-dihydroxy-6(E)-heptanoic acid hemi magnesium. The structural formula is. The molecular formula for pitavastatin is C50H46MgF2N2O8 and the molecular weight is 865.21. Pitavastatin is a white to off-white powder. It is freely soluble in acetone, ethyl acetate; soluble in dimethylsulfoxide and insoluble in dichloromethane and isopropyl alcohol. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of ZYPITAMAG contains 2.053 mg or 4.106 mg of pitavastatin magnesium, which is equivalent to 2 mg or 4 mg, respectively of free base and the following inactive ingredients: calcium carbonate, crospovidone, hypromellose, lactose monohydrate, magnesium stearate and sodium carbonate anhydrous and film-coating containing the following inactive ingredients: hypromellose, polyethylene glycol, talc and titanium dioxide."
},
{
"NDCCode": "42507-865-03",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (42507-865-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "42507-0865-03",
"ProductNDC": "42507-865",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202312",
"LabelerName": "HYVEE INC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260113",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachemuscular achesminor pain of arthritistoothachebackachethe common coldmenstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "54458-865-10",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-865-10)",
"NDC11Code": "54458-0865-10",
"ProductNDC": "54458-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077210",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"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 exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets 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 hydrochloride 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. C19H20N2O3SHCl M.W. 392.90. Pioglitazone hydrochloride, USP is an odorless white crystalline powder. 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 tablets USP are available for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, and mannitol."
},
{
"NDCCode": "61919-865-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (61919-865-30) ",
"NDC11Code": "61919-0865-30",
"ProductNDC": "61919-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hcl C-iv",
"NonProprietaryName": "Phentermine Hcl C-iv",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091359",
"LabelerName": "Direct_Rx",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190605",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0\" 5'3\" 5'6\" 5'9\" 6'0\" 6'3\" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. [Phentermine HCl Molecular Structure]. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake."
},
{
"NDCCode": "61919-865-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (61919-865-90) ",
"NDC11Code": "61919-0865-90",
"ProductNDC": "61919-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hcl C-iv",
"NonProprietaryName": "Phentermine Hcl C-iv",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091359",
"LabelerName": "Direct_Rx",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190605",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0\" 5'3\" 5'6\" 5'9\" 6'0\" 6'3\" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. [Phentermine HCl Molecular Structure]. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake."
},
{
"NDCCode": "63285-865-00",
"PackageDescription": "30194 TABLET in 1 DRUM (63285-865-00)",
"NDC11Code": "63285-0865-00",
"ProductNDC": "63285-865",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"StartMarketingDate": "20101028",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Patheon, Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2021-01-15",
"ListingRecordCertifiedThrough": "20221231"
},
{
"NDCCode": "65862-865-83",
"PackageDescription": "3 POUCH in 1 CARTON (65862-865-83) / 1 BLISTER PACK in 1 POUCH (65862-865-94) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "65862-0865-83",
"ProductNDC": "65862-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iclevia",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206850",
"LabelerName": "Aurobindo Pharma Limited",
"Status": "Active",
"LastUpdate": "2024-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180629",
"SamplePackage": "N",
"IndicationAndUsage": "IcleviaTM (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Iclevia (levonorgestrel and ethinyl estradiol tablets USP) is an extended-cycle combination oral contraceptive consisting of 84 white active tablets each containing 0.15 mg of levonorgestrel USP, a synthetic progestin and 0.03 mg of ethinyl estradiol USP, an estrogen, and 7 green inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-."
},
{
"NDCCode": "69097-865-17",
"PackageDescription": "6 TABLET in 1 BLISTER PACK (69097-865-17) ",
"NDC11Code": "69097-0865-17",
"ProductNDC": "69097-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204339",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160722",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1). Limitations of Use: 1 Use only after clear diagnosis of migraine has been established (1), 2 Not indicated for the prophylactic therapy of migraine (1), 3 Not indicated for the treatment of cluster headache (1).",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch (corn starch), pregelatinized starch ( maize), colloidal silicon dioxide, ferric oxide (red), and magnesium stearate."
},
{
"NDCCode": "69097-865-85",
"PackageDescription": "3 TABLET in 1 CARTON (69097-865-85) ",
"NDC11Code": "69097-0865-85",
"ProductNDC": "69097-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204339",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160722",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1). Limitations of Use: 1 Use only after clear diagnosis of migraine has been established (1), 2 Not indicated for the prophylactic therapy of migraine (1), 3 Not indicated for the treatment of cluster headache (1).",
"Description": "Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch (corn starch), pregelatinized starch ( maize), colloidal silicon dioxide, ferric oxide (red), and magnesium stearate."
}
]
}
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<NDC>
<NDCCode>70512-865-15</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70512-865-15) / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>70512-0865-15</NDC11Code>
<ProductNDC>70512-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215183</ApplicationNumber>
<LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless, topical - adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy- [(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C 9H 13NO 2.HCl Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
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<NDC>
<NDCCode>70512-865-02</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70512-865-02) / 2 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>70512-0865-02</NDC11Code>
<ProductNDC>70512-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215183</ApplicationNumber>
<LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless, topical - adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy- [(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C 9H 13NO 2.HCl Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
</NDC>
<NDC>
<NDCCode>70512-011-15</NDCCode>
<PackageDescription>3 POUCH in 1 BOX (70512-011-15) > 1 g in 1 POUCH</PackageDescription>
<NDC11Code>70512-0011-15</NDC11Code>
<ProductNDC>70512-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lenza Pro</ProprietaryName>
<NonProprietaryName>Lidocaine/menthol Patch</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180208</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Sola Pharmaceuticals</LabelerName>
<SubstanceName>LIDOCAINE; MENTHOL</SubstanceName>
<StrengthNumber>40; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70512-013-15</NDCCode>
<PackageDescription>3 POUCH in 1 BOX (70512-013-15) / 1 g in 1 POUCH</PackageDescription>
<NDC11Code>70512-0013-15</NDC11Code>
<ProductNDC>70512-013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lenzapro Flex</ProprietaryName>
<NonProprietaryName>Lidocaine/menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>SOLA Pharmaceuticals</LabelerName>
<SubstanceName>MENTHOL; LIDOCAINE</SubstanceName>
<StrengthNumber>40; 40</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For the temporary relief of pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70512-015-15</NDCCode>
<PackageDescription>3 POUCH in 1 BOX (70512-015-15) / 5 g in 1 POUCH</PackageDescription>
<NDC11Code>70512-0015-15</NDC11Code>
<ProductNDC>70512-015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Synoflex Patch</ProprietaryName>
<NonProprietaryName>Synoflex Patch</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220428</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Sola Pharmaceuticals</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; MENTHOL</SubstanceName>
<StrengthNumber>40; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70512-017-15</NDCCode>
<PackageDescription>3 POUCH in 1 BOX (70512-017-15) / 5 g in 1 POUCH</PackageDescription>
<NDC11Code>70512-0017-15</NDC11Code>
<ProductNDC>70512-017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triceptin</ProprietaryName>
<NonProprietaryName>Lidocaine / Menthol / Methyl Salicylate</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221205</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>SOLA Pharmaceuticals</LabelerName>
<SubstanceName>LIDOCAINE; METHYL SALICYLATE; MENTHOL</SubstanceName>
<StrengthNumber>40; 20; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: 1 Muscle soreness, 2 strains, 3 sprains, 4 arthritis, 5 simple backache, 6 muscle stiffness, 7 bruises.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70512-020-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (70512-020-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>70512-0020-15</NDC11Code>
<ProductNDC>70512-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate Oint 0.05%</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate Oint 0.05%</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208589</ApplicationNumber>
<LabelerName>Sola Pharmaceuticals</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70512-028-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (70512-028-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>70512-0028-15</NDC11Code>
<ProductNDC>70512-028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate Cream</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209974</ApplicationNumber>
<LabelerName>Sola Pharmaceuticals</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70512-100-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (70512-100-15) > 14.2 g in 1 TUBE</PackageDescription>
<NDC11Code>70512-0100-15</NDC11Code>
<ProductNDC>70512-100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole Cream 1%</ProprietaryName>
<NonProprietaryName>Clotrimazole Cream 1%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200414</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>SOLA Pharmaceuticals</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For External treatment of most athlete's foot (tinea pedis), jock ithc (tinea crusis), ringworm (tinea corporis). Relieves itching, cracking scaling irritation and chafing associated with these conditions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14593-865-02</NDCCode>
<PackageDescription>15 kg in 1 DRUM (14593-865-02) </PackageDescription>
<NDC11Code>14593-0865-02</NDC11Code>
<ProductNDC>14593-865</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Busulfan</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20231225</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
<SubstanceName>BUSULFAN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>kg/5kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-27</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-DEC-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>35356-865-15</NDCCode>
<PackageDescription>15 CAPSULE in 1 BOTTLE (35356-865-15)</PackageDescription>
<NDC11Code>35356-0865-15</NDC11Code>
<ProductNDC>35356-865</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diphenhydramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>41520-865-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (41520-865-05) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>41520-0865-05</NDC11Code>
<ProductNDC>41520-865</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Artificial Tears</ProprietaryName>
<NonProprietaryName>Glycerin, Hypromellose, Polyethylene Glycol 400</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20100906</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>American Sales Company</LabelerName>
<SubstanceName>GLYCERIN; POLYETHYLENE GLYCOL 400; HYPROMELLOSES</SubstanceName>
<StrengthNumber>2; 10; 2</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64762-865-15</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (64762-865-15) > 15 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>64762-0865-15</NDC11Code>
<ProductNDC>64762-865</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oxymetazoline Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20091104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Dynamic Pharmaceuticals</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/.4mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily relieves nasal congestion due to: 1 common cold, 2 hay fever, 3 upper respiratory allergies, 4 helps clear nasal passages, 5 shrinks swollen membranes, 6 temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-865-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE (71610-865-15) </PackageDescription>
<NDC11Code>71610-0865-15</NDC11Code>
<ProductNDC>71610-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075977</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride, USP is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride. Its structural formula is:. C 16H 25NO 2HCl M.W. 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP (equivalent to 43.9 mg of tramadol) and are white in color. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 4000, pregelatinized corn starch, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76420-865-15</NDCCode>
<PackageDescription>150 TABLET in 1 BOTTLE (76420-865-15) </PackageDescription>
<NDC11Code>76420-0865-15</NDC11Code>
<ProductNDC>76420-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076286</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine tablet is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1) ].</IndicationAndUsage>
<Description>Tizanidine hydrochloride USP, is a central α 2-adrenergic agonist. Tizanidine hydrochloride USP is almost white to slightly yellow crystalline powder, which is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole monohydrochloride. Tizanidine’s molecular formula is C 9H 8ClN 5S.HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine tablets USP, are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets USP, contain the active ingredient, tizanidine hydrochloride USP (2.288 mg equivalent to 2 mg tizanidine base and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, microcrystalline cellulose, colloidal silicon dioxide and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>84756-865-02</NDCCode>
<PackageDescription>15 g in 1 BOX (84756-865-02) </PackageDescription>
<NDC11Code>84756-0865-02</NDC11Code>
<ProductNDC>84756-865</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lift Firm Booty Mask</ProprietaryName>
<NonProprietaryName>Lift Firm Booty Mask</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70512-842-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (70512-842-25) / 1 mL in 1 VIAL (70512-842-01) </PackageDescription>
<NDC11Code>70512-0842-25</NDC11Code>
<ProductNDC>70512-842</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217789</ApplicationNumber>
<LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients. Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS).Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
<Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1 H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) of ketorolac tromethamine in sterile solution. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, and 4.35 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
</NDC>
<NDC>
<NDCCode>70512-843-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (70512-843-25) / 1 mL in 1 VIAL (70512-843-01) </PackageDescription>
<NDC11Code>70512-0843-25</NDC11Code>
<ProductNDC>70512-843</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217789</ApplicationNumber>
<LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients. Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS).Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
<Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1 H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) of ketorolac tromethamine in sterile solution. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, and 4.35 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
</NDC>
<NDC>
<NDCCode>70512-844-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (70512-844-25) / 2 mL in 1 VIAL (70512-844-01) </PackageDescription>
<NDC11Code>70512-0844-25</NDC11Code>
<ProductNDC>70512-844</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20241022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217789</ApplicationNumber>
<LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients. Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS).Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
<Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1 H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) of ketorolac tromethamine in sterile solution. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, and 4.35 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
</NDC>
<NDC>
<NDCCode>70512-859-05</NDCCode>
<PackageDescription>5 VIAL, SINGLE-DOSE in 1 CARTON (70512-859-05) / 1 mL in 1 VIAL, SINGLE-DOSE (70512-859-01) </PackageDescription>
<NDC11Code>70512-0859-05</NDC11Code>
<ProductNDC>70512-859</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboprost Tromethamine</ProprietaryName>
<NonProprietaryName>Carboprost Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20230925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216824</ApplicationNumber>
<LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CARBOPROST TROMETHAMINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carboprost tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1 Failure of expulsion of the fetus during the course of treatment by another method; , 2 Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; , 3 Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; , 4 Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.</IndicationAndUsage>
<Description>Carboprost tromethamine injection, USP, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in carboprost tromethamine injection, USP. Four other chemical names are: : 1 (15S)-15-methyl prostaglandin F2α tromethamine salt , 2 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α-cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol , 3 (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt , 4 (15S)-15-methyl PGF2α-THAM .</Description>
</NDC>
<NDC>
<NDCCode>25208-201-15</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (25208-201-15) </PackageDescription>
<NDC11Code>25208-0201-15</NDC11Code>
<ProductNDC>25208-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zypitamag</ProprietaryName>
<NonProprietaryName>Pitavastatin Magnesium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208379</ApplicationNumber>
<LabelerName>Medicure International Inc</LabelerName>
<SubstanceName>PITAVASTATIN</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZYPITAMAG is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Pediatric use information is approved for Kowa Co Ltd LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>ZYPITAMAG (pitavastatin) tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (3R,5S)-7-[2-Cyclopropyl-4-(4-fluorophenyl) quinoline-3-yl]3,5-dihydroxy-6(E)-heptanoic acid hemi magnesium. The structural formula is. The molecular formula for pitavastatin is C50H46MgF2N2O8 and the molecular weight is 865.21. Pitavastatin is a white to off-white powder. It is freely soluble in acetone, ethyl acetate; soluble in dimethylsulfoxide and insoluble in dichloromethane and isopropyl alcohol. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of ZYPITAMAG contains 2.053 mg or 4.106 mg of pitavastatin magnesium, which is equivalent to 2 mg or 4 mg, respectively of free base and the following inactive ingredients: calcium carbonate, crospovidone, hypromellose, lactose monohydrate, magnesium stearate and sodium carbonate anhydrous and film-coating containing the following inactive ingredients: hypromellose, polyethylene glycol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>25208-202-15</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (25208-202-15) </PackageDescription>
<NDC11Code>25208-0202-15</NDC11Code>
<ProductNDC>25208-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zypitamag</ProprietaryName>
<NonProprietaryName>Pitavastatin Magnesium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208379</ApplicationNumber>
<LabelerName>Medicure International Inc</LabelerName>
<SubstanceName>PITAVASTATIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZYPITAMAG is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Pediatric use information is approved for Kowa Co Ltd LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>ZYPITAMAG (pitavastatin) tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (3R,5S)-7-[2-Cyclopropyl-4-(4-fluorophenyl) quinoline-3-yl]3,5-dihydroxy-6(E)-heptanoic acid hemi magnesium. The structural formula is. The molecular formula for pitavastatin is C50H46MgF2N2O8 and the molecular weight is 865.21. Pitavastatin is a white to off-white powder. It is freely soluble in acetone, ethyl acetate; soluble in dimethylsulfoxide and insoluble in dichloromethane and isopropyl alcohol. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of ZYPITAMAG contains 2.053 mg or 4.106 mg of pitavastatin magnesium, which is equivalent to 2 mg or 4 mg, respectively of free base and the following inactive ingredients: calcium carbonate, crospovidone, hypromellose, lactose monohydrate, magnesium stearate and sodium carbonate anhydrous and film-coating containing the following inactive ingredients: hypromellose, polyethylene glycol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42507-865-03</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (42507-865-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>42507-0865-03</NDC11Code>
<ProductNDC>42507-865</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202312</ApplicationNumber>
<LabelerName>HYVEE INC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachemuscular achesminor pain of arthritistoothachebackachethe common coldmenstrual cramps. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54458-865-10</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (54458-865-10)</PackageDescription>
<NDC11Code>54458-0865-10</NDC11Code>
<ProductNDC>54458-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077210</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<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 exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets 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 hydrochloride 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. C19H20N2O3SHCl M.W. 392.90. Pioglitazone hydrochloride, USP is an odorless white crystalline powder. 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 tablets USP are available for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, and mannitol.</Description>
</NDC>
<NDC>
<NDCCode>61919-865-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (61919-865-30) </PackageDescription>
<NDC11Code>61919-0865-30</NDC11Code>
<ProductNDC>61919-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hcl C-iv</ProprietaryName>
<NonProprietaryName>Phentermine Hcl C-iv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091359</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. [Phentermine HCl Molecular Structure]. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>61919-865-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (61919-865-90) </PackageDescription>
<NDC11Code>61919-0865-90</NDC11Code>
<ProductNDC>61919-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hcl C-iv</ProprietaryName>
<NonProprietaryName>Phentermine Hcl C-iv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091359</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. [Phentermine HCl Molecular Structure]. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>63285-865-00</NDCCode>
<PackageDescription>30194 TABLET in 1 DRUM (63285-865-00)</PackageDescription>
<NDC11Code>63285-0865-00</NDC11Code>
<ProductNDC>63285-865</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20101028</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Patheon, Inc.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2021-01-15</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65862-865-83</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (65862-865-83) / 1 BLISTER PACK in 1 POUCH (65862-865-94) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65862-0865-83</NDC11Code>
<ProductNDC>65862-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iclevia</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206850</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IcleviaTM (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Iclevia (levonorgestrel and ethinyl estradiol tablets USP) is an extended-cycle combination oral contraceptive consisting of 84 white active tablets each containing 0.15 mg of levonorgestrel USP, a synthetic progestin and 0.03 mg of ethinyl estradiol USP, an estrogen, and 7 green inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-.</Description>
</NDC>
<NDC>
<NDCCode>69097-865-17</NDCCode>
<PackageDescription>6 TABLET in 1 BLISTER PACK (69097-865-17) </PackageDescription>
<NDC11Code>69097-0865-17</NDC11Code>
<ProductNDC>69097-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204339</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1). Limitations of Use: 1 Use only after clear diagnosis of migraine has been established (1), 2 Not indicated for the prophylactic therapy of migraine (1), 3 Not indicated for the treatment of cluster headache (1).</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch (corn starch), pregelatinized starch ( maize), colloidal silicon dioxide, ferric oxide (red), and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>69097-865-85</NDCCode>
<PackageDescription>3 TABLET in 1 CARTON (69097-865-85) </PackageDescription>
<NDC11Code>69097-0865-85</NDC11Code>
<ProductNDC>69097-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204339</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1). Limitations of Use: 1 Use only after clear diagnosis of migraine has been established (1), 2 Not indicated for the prophylactic therapy of migraine (1), 3 Not indicated for the treatment of cluster headache (1).</IndicationAndUsage>
<Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch (corn starch), pregelatinized starch ( maize), colloidal silicon dioxide, ferric oxide (red), and magnesium stearate.</Description>
</NDC>
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