{
"NDC": [
{
"NDCCode": "52763-602-40",
"PackageDescription": "240 g in 1 BOTTLE, PUMP (52763-602-40)",
"NDC11Code": "52763-0602-40",
"ProductNDC": "52763-602",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simply Numb Endure",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140708",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Golden Touch LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the temporary relief of pain and itching."
},
{
"NDCCode": "52763-502-40",
"PackageDescription": "240 g in 1 BOTTLE, PUMP (52763-502-40)",
"NDC11Code": "52763-0502-40",
"ProductNDC": "52763-502",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocream 5",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Golden Touch LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the temporary relief of pain and itching due to anorectal disorders."
},
{
"NDCCode": "37000-602-40",
"PackageDescription": "1200 mL in 1 BAG (37000-602-40) ",
"NDC11Code": "37000-0602-40",
"ProductNDC": "37000-602",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Safeguard",
"ProprietaryNameSuffix": "Antibacterial E2 Foaming",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".12",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100701",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "54860-602-01",
"PackageDescription": "40 mL in 1 BOTTLE, SPRAY (54860-602-01) ",
"NDC11Code": "54860-0602-01",
"ProductNDC": "54860-602",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Care Holiday Hand Sanitizer-gingerbread",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260618",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Shenzhen Lantern Scicence Co.,Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260622",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and children 6 years and older Spray onto hands and rub together unil dry. Recommended for repeat use. Children under 6 years of age should be supervised when using this product."
},
{
"NDCCode": "66915-602-40",
"PackageDescription": "15 g in 1 BOTTLE, PLASTIC (66915-602-40)",
"NDC11Code": "66915-0602-40",
"ProductNDC": "66915-602",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sol Protect",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CoValence, Inc.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": ".0702",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "68828-602-01",
"PackageDescription": "1 TUBE in 1 CARTON (68828-602-01) / 40 mL in 1 TUBE",
"NDC11Code": "68828-0602-01",
"ProductNDC": "68828-602",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jafra Biolab Dark Spot Corrector Facial Cream Broad Spectrum Spf 30 Sunscreen",
"NonProprietaryName": "Avobenzone,homosalate,octisalate,octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Distribuidora Comercial Jafra, S.A. de C.V.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 7; 5; 10",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging. caused by the sun."
},
{
"NDCCode": "70186-602-01",
"PackageDescription": "1 TUBE in 1 CARTON (70186-602-01) > 40 mL in 1 TUBE",
"NDC11Code": "70186-0602-01",
"ProductNDC": "70186-602",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Light Wonder Your Light, Dream Skin Foundation Sunscreen Broad Spectrum Spf 15",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Charlotte Tilbury Beauty Ltd.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "1.76; 1",
"StrengthUnit": "g/40mL; g/40mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190601",
"SamplePackage": "N",
"IndicationAndUsage": " Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "10135-602-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (10135-602-90)",
"NDC11Code": "10135-0602-90",
"ProductNDC": "10135-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felbamate",
"NonProprietaryName": "Felbamate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201680",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "FELBAMATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate tablets, USP can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.",
"Description": "Felbamate, USP is an antiepileptic available as 400mg and 600mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate’s molecular formula is C₁₁H₁₄N₂O₄; its structural formula is:. The inactive ingredients for felbamate tablets, USP 400 mg and 600 mg are croscarmellose sodium. FD&C Yellow No. 6, D&C Yellow No. 10 and FD&C Red No. 40 (600 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch."
},
{
"NDCCode": "42747-602-07",
"PackageDescription": "1 BLISTER PACK in 1 BOX (42747-602-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "42747-0602-07",
"ProductNDC": "42747-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nourianz",
"NonProprietaryName": "Istradefylline",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190827",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022075",
"LabelerName": "Kyowa Kirin, Inc.",
"SubstanceName": "ISTRADEFYLLINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190827",
"SamplePackage": "Y",
"IndicationAndUsage": "NOURIANZ is indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing \"off\" episodes.",
"Description": "NOURIANZ contains istradefylline, an adenosine receptor antagonist, which has a xanthine derivative structure. The chemical name is (E)-8-(3,4-dimethoxystyryl)-1,3-diethyl-7-methyl-3,7-dihydro-1H-purine-2,6-dione. Its molecular formula is C20H24N4O4. The molecular weight is 384.43. Istradefylline has the following structural formula. Istradefylline is a light yellow-green crystalline powder. Istradefylline has a dissociation constant (pKa) of 0.78. The aqueous solubility of istradefylline is ~0.5 µg/mL across the physiological pH range and 0.6 µg/mL in water. NOURIANZ tablets are intended for oral administration only. Each tablet contains 20 mg or 40 mg of istradefylline and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinyl alcohol. The film coating contains hypromellose, lactose monohydrate, polyethylene glycol 3350, titanium dioxide, triacetin, and the following dyes: iron oxide red and iron oxide yellow. Carnauba wax is used for polishing."
},
{
"NDCCode": "42747-602-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42747-602-90) ",
"NDC11Code": "42747-0602-90",
"ProductNDC": "42747-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nourianz",
"NonProprietaryName": "Istradefylline",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190827",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022075",
"LabelerName": "Kyowa Kirin, Inc.",
"SubstanceName": "ISTRADEFYLLINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190827",
"SamplePackage": "N",
"IndicationAndUsage": "NOURIANZ is indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing \"off\" episodes.",
"Description": "NOURIANZ contains istradefylline, an adenosine receptor antagonist, which has a xanthine derivative structure. The chemical name is (E)-8-(3,4-dimethoxystyryl)-1,3-diethyl-7-methyl-3,7-dihydro-1H-purine-2,6-dione. Its molecular formula is C20H24N4O4. The molecular weight is 384.43. Istradefylline has the following structural formula. Istradefylline is a light yellow-green crystalline powder. Istradefylline has a dissociation constant (pKa) of 0.78. The aqueous solubility of istradefylline is ~0.5 µg/mL across the physiological pH range and 0.6 µg/mL in water. NOURIANZ tablets are intended for oral administration only. Each tablet contains 20 mg or 40 mg of istradefylline and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinyl alcohol. The film coating contains hypromellose, lactose monohydrate, polyethylene glycol 3350, titanium dioxide, triacetin, and the following dyes: iron oxide red and iron oxide yellow. Carnauba wax is used for polishing."
},
{
"NDCCode": "43547-602-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (43547-602-10) ",
"NDC11Code": "43547-0602-10",
"ProductNDC": "43547-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine Dimesylate Capsules",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230826",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216266",
"LabelerName": "Solco Healthcare US,LLC",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230826",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].",
"Description": "Lisdexamfetamine dimesylate capsules, a CNS stimulant, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino‑N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The imprinting ink for all strengths contain D&C yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, iron oxide black, potassium hydroxide, propylene glycol and shellac glaze. The capsule shells of each strength contain ingredients as below."
},
{
"NDCCode": "51655-602-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (51655-602-20) ",
"NDC11Code": "51655-0602-20",
"ProductNDC": "51655-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metaxalone",
"NonProprietaryName": "Metaxalone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208774",
"LabelerName": "Northwind Pharmaceuticals",
"SubstanceName": "METAXALONE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210219",
"SamplePackage": "N",
"IndicationAndUsage": "Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.",
"Description": "Metaxalone tablets, USP are available as an 800 mg oval, scored pink tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C 12H 15NO 3, which corresponds to a molecular weight of 221.25. The structural formula is:. Metaxalone is a white crystalline powder, soluble in chloroform, acetonitrile and methanol, but insoluble in water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: anhydrous citric acid, FD&C Red # 40, sodium alginate and magnesium stearate. USP Dissolution Test Pending."
},
{
"NDCCode": "60951-602-70",
"PackageDescription": "100 TABLET in 1 BOTTLE (60951-602-70) ",
"NDC11Code": "60951-0602-70",
"ProductNDC": "60951-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Endocet",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20000526",
"EndMarketingDate": "20270331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040330",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000526",
"EndMarketingDatePackage": "20270331",
"SamplePackage": "N",
"IndicationAndUsage": "ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
},
{
"NDCCode": "60951-602-85",
"PackageDescription": "500 TABLET in 1 BOTTLE (60951-602-85) ",
"NDC11Code": "60951-0602-85",
"ProductNDC": "60951-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Endocet",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20000526",
"EndMarketingDate": "20270331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040330",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000526",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "N",
"IndicationAndUsage": "ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula."
},
{
"NDCCode": "64980-602-03",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (64980-602-03) ",
"NDC11Code": "64980-0602-03",
"ProductNDC": "64980-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208659",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240330",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablet are indicated for the treatment of hypertension, in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil USP is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets USP is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil USP and the following inactive ingredients: hydroxy propyl cellulose, hypromellose, lactose monohydrate, low substituted HPC, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and yellow iron oxide (5 mg only)."
},
{
"NDCCode": "64980-602-09",
"PackageDescription": "90 TABLET, COATED in 1 BOTTLE (64980-602-09) ",
"NDC11Code": "64980-0602-09",
"ProductNDC": "64980-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208659",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240330",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablet are indicated for the treatment of hypertension, in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil USP is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets USP is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil USP and the following inactive ingredients: hydroxy propyl cellulose, hypromellose, lactose monohydrate, low substituted HPC, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and yellow iron oxide (5 mg only)."
},
{
"NDCCode": "66312-602-16",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (66312-602-16) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "66312-0602-16",
"ProductNDC": "66312-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Articadent",
"NonProprietaryName": "Articaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020971",
"LabelerName": "Dentsply Pharmaceutical",
"SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .005",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
"Description": "ARTICADENT (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength. Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. ARTICADENT contains the following inactive ingredients: sodium chloride (1.6 mg/mL), and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
},
{
"NDCCode": "66336-602-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (66336-602-30)",
"NDC11Code": "66336-0602-30",
"ProductNDC": "66336-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075991",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin is indicated to reduce the risk of: : 1 Myocardial infarction , 2 Unstable angina , 3 Coronary revascularization procedures .",
"Description": "Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1 S -[1α(R *), 3α, 7β, 8β(2 S *,4 S *),8aβ]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C 24 H 36 O 5 and its molecular weight is 404.55. Its structural formula is:. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, pregelatinized starch, sodium starch glycolate, butylated hydroxyaniso and talc. Butylated hydroxyanisole (BHA) is added as a preservative."
},
{
"NDCCode": "68083-602-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (68083-602-01) / 5 mL in 1 BOTTLE",
"NDC11Code": "68083-0602-01",
"ProductNDC": "68083-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Travoprost Ophthalmic Solution",
"NonProprietaryName": "Travoprost Ophthalmic Solution",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218159",
"LabelerName": "Gland Pharma Limited",
"SubstanceName": "TRAVOPROST",
"StrengthNumber": ".04",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240712",
"SamplePackage": "N",
"IndicationAndUsage": "Travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.",
"Description": "Travoprost is a synthetic prostaglandin F analog. Its chemical name is [1R-[1α(Z),2β(1E,3R*),3α,5α]]-7-[3,5-Dihydroxy-2-[3-hydroxy-4-[3-(trifluoromethyl) phenoxy]-1-butenyl]cyclopentyl]-5-heptenoic acid, 1-methylethylester. It has a molecular formula of C26H35F3O6 and a molecular weight of 500.55 g/mol. The chemical structure of travoprost is. Travoprost, USP is a clear, colorless and viscous oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. It is practically insoluble in water. Travoprost ophthalmic solution, USP (ionic buffered solution) 0.004% is supplied as sterile, buffered aqueous solution of travoprost with a pH of approximately 5.7 and an osmolality of approximately 290 mOsmol/kg. Travoprost ophthalmic solution, USP (ionic buffered solution) 0.004% contains Active: travoprost, USP 0.04 mg/mL; Inactives: polyoxyl 40 hydrogenated castor oil, boric acid, propylene glycol, sorbitol, zinc chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. Preserved in the bottle with an ionic buffered system."
},
{
"NDCCode": "69292-602-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (69292-602-01) ",
"NDC11Code": "69292-0602-01",
"ProductNDC": "69292-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075584",
"LabelerName": "Amici Pharma, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260521",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].",
"Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride tablets, USP are supplied for oral administration as 75-mg and 100-mg lavender film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients. FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, hypromellose, microcrystalline cellulose, potassium chloride, pregelatinized starch, stearic acid, titanium dioxide, and triethyl citrate."
},
{
"NDCCode": "71205-602-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-602-30) ",
"NDC11Code": "71205-0602-30",
"ProductNDC": "71205-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208706",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2022-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210820",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending."
},
{
"NDCCode": "71205-602-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-602-60) ",
"NDC11Code": "71205-0602-60",
"ProductNDC": "71205-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208706",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2022-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210820",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending."
},
{
"NDCCode": "71205-602-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-602-90) ",
"NDC11Code": "71205-0602-90",
"ProductNDC": "71205-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208706",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2022-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210820",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending."
},
{
"NDCCode": "75854-602-02",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (75854-602-02) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "75854-0602-02",
"ProductNDC": "75854-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Balcoltra",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180410",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208612",
"LabelerName": "Avion Pharmaceuticals",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180410",
"SamplePackage": "N",
"IndicationAndUsage": "Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound. 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate. The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch. Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake. Levonorgestrel has the empirical formula of C21H28O2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C20H24O2 and the molecular weight of 296.4. The molecular structures are provided below."
},
{
"NDCCode": "75854-602-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (75854-602-03) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "75854-0602-03",
"ProductNDC": "75854-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Balcoltra",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180410",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208612",
"LabelerName": "Avion Pharmaceuticals",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180410",
"SamplePackage": "N",
"IndicationAndUsage": "Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound. 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate. The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch. Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake. Levonorgestrel has the empirical formula of C21H28O2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C20H24O2 and the molecular weight of 296.4. The molecular structures are provided below."
},
{
"NDCCode": "75854-602-28",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (75854-602-28) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "75854-0602-28",
"ProductNDC": "75854-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Balcoltra",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180410",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208612",
"LabelerName": "Avion Pharmaceuticals",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180410",
"SamplePackage": "N",
"IndicationAndUsage": "Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound. 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate. The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch. Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake. Levonorgestrel has the empirical formula of C21H28O2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C20H24O2 and the molecular weight of 296.4. The molecular structures are provided below."
},
{
"NDCCode": "81877-602-04",
"PackageDescription": "118 mL in 1 BOTTLE, GLASS (81877-602-04) ",
"NDC11Code": "81877-0602-04",
"ProductNDC": "81877-602",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Methyl Salicylate 40% Topical Oil",
"NonProprietaryName": "Methyl Salicylate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230303",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "FORREAL PHARMACEUTICALS LLC",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "40",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230303",
"SamplePackage": "N"
},
{
"NDCCode": "52763-101-60",
"PackageDescription": "1 TUBE in 1 CARTON (52763-101-60) > 60 g in 1 TUBE",
"NDC11Code": "52763-0101-60",
"ProductNDC": "52763-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocream 10",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150505",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Golden Touch LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "10",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses For the temporary relief of pain and itching due to anorectal disorders."
},
{
"NDCCode": "52763-401-30",
"PackageDescription": "1 TUBE in 1 CARTON (52763-401-30) > 30 g in 1 TUBE",
"NDC11Code": "52763-0401-30",
"ProductNDC": "52763-401",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocream 4",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Golden Touch LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "4",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the temporary relief of pain and itching due to: 1 minor burns, 2 minor skin irritations, 3 minor cuts, 4 scrapes, 5 sunburn, 6 insect bites."
},
{
"NDCCode": "52763-401-60",
"PackageDescription": "1 TUBE in 1 CARTON (52763-401-60) > 60 g in 1 TUBE",
"NDC11Code": "52763-0401-60",
"ProductNDC": "52763-401",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocream 4",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Golden Touch LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "4",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the temporary relief of pain and itching due to: 1 minor burns, 2 minor skin irritations."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>52763-602-40</NDCCode>
<PackageDescription>240 g in 1 BOTTLE, PUMP (52763-602-40)</PackageDescription>
<NDC11Code>52763-0602-40</NDC11Code>
<ProductNDC>52763-602</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simply Numb Endure</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140708</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>Golden Touch LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the temporary relief of pain and itching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52763-502-40</NDCCode>
<PackageDescription>240 g in 1 BOTTLE, PUMP (52763-502-40)</PackageDescription>
<NDC11Code>52763-0502-40</NDC11Code>
<ProductNDC>52763-502</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocream 5</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>Golden Touch LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the temporary relief of pain and itching due to anorectal disorders.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37000-602-40</NDCCode>
<PackageDescription>1200 mL in 1 BAG (37000-602-40) </PackageDescription>
<NDC11Code>37000-0602-40</NDC11Code>
<ProductNDC>37000-602</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Safeguard</ProprietaryName>
<ProprietaryNameSuffix>Antibacterial E2 Foaming</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.12</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54860-602-01</NDCCode>
<PackageDescription>40 mL in 1 BOTTLE, SPRAY (54860-602-01) </PackageDescription>
<NDC11Code>54860-0602-01</NDC11Code>
<ProductNDC>54860-602</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care Holiday Hand Sanitizer-gingerbread</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260618</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Shenzhen Lantern Scicence Co.,Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and children 6 years and older Spray onto hands and rub together unil dry. Recommended for repeat use. Children under 6 years of age should be supervised when using this product.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66915-602-40</NDCCode>
<PackageDescription>15 g in 1 BOTTLE, PLASTIC (66915-602-40)</PackageDescription>
<NDC11Code>66915-0602-40</NDC11Code>
<ProductNDC>66915-602</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sol Protect</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CoValence, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>.0702</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>68828-602-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68828-602-01) / 40 mL in 1 TUBE</PackageDescription>
<NDC11Code>68828-0602-01</NDC11Code>
<ProductNDC>68828-602</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Jafra Biolab Dark Spot Corrector Facial Cream Broad Spectrum Spf 30 Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone,homosalate,octisalate,octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Distribuidora Comercial Jafra, S.A. de C.V.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 7; 5; 10</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging. caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70186-602-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (70186-602-01) > 40 mL in 1 TUBE</PackageDescription>
<NDC11Code>70186-0602-01</NDC11Code>
<ProductNDC>70186-602</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Light Wonder Your Light, Dream Skin Foundation Sunscreen Broad Spectrum Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Charlotte Tilbury Beauty Ltd.</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.76; 1</StrengthNumber>
<StrengthUnit>g/40mL; g/40mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10135-602-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (10135-602-90)</PackageDescription>
<NDC11Code>10135-0602-90</NDC11Code>
<ProductNDC>10135-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Felbamate</ProprietaryName>
<NonProprietaryName>Felbamate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201680</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>FELBAMATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate tablets, USP can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.</IndicationAndUsage>
<Description>Felbamate, USP is an antiepileptic available as 400mg and 600mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate’s molecular formula is C₁₁H₁₄N₂O₄; its structural formula is:. The inactive ingredients for felbamate tablets, USP 400 mg and 600 mg are croscarmellose sodium. FD&C Yellow No. 6, D&C Yellow No. 10 and FD&C Red No. 40 (600 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>42747-602-07</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (42747-602-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42747-0602-07</NDC11Code>
<ProductNDC>42747-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nourianz</ProprietaryName>
<NonProprietaryName>Istradefylline</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190827</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022075</ApplicationNumber>
<LabelerName>Kyowa Kirin, Inc.</LabelerName>
<SubstanceName>ISTRADEFYLLINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190827</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>NOURIANZ is indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes.</IndicationAndUsage>
<Description>NOURIANZ contains istradefylline, an adenosine receptor antagonist, which has a xanthine derivative structure. The chemical name is (E)-8-(3,4-dimethoxystyryl)-1,3-diethyl-7-methyl-3,7-dihydro-1H-purine-2,6-dione. Its molecular formula is C20H24N4O4. The molecular weight is 384.43. Istradefylline has the following structural formula. Istradefylline is a light yellow-green crystalline powder. Istradefylline has a dissociation constant (pKa) of 0.78. The aqueous solubility of istradefylline is ~0.5 µg/mL across the physiological pH range and 0.6 µg/mL in water. NOURIANZ tablets are intended for oral administration only. Each tablet contains 20 mg or 40 mg of istradefylline and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinyl alcohol. The film coating contains hypromellose, lactose monohydrate, polyethylene glycol 3350, titanium dioxide, triacetin, and the following dyes: iron oxide red and iron oxide yellow. Carnauba wax is used for polishing.</Description>
</NDC>
<NDC>
<NDCCode>42747-602-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42747-602-90) </PackageDescription>
<NDC11Code>42747-0602-90</NDC11Code>
<ProductNDC>42747-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nourianz</ProprietaryName>
<NonProprietaryName>Istradefylline</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190827</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022075</ApplicationNumber>
<LabelerName>Kyowa Kirin, Inc.</LabelerName>
<SubstanceName>ISTRADEFYLLINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOURIANZ is indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes.</IndicationAndUsage>
<Description>NOURIANZ contains istradefylline, an adenosine receptor antagonist, which has a xanthine derivative structure. The chemical name is (E)-8-(3,4-dimethoxystyryl)-1,3-diethyl-7-methyl-3,7-dihydro-1H-purine-2,6-dione. Its molecular formula is C20H24N4O4. The molecular weight is 384.43. Istradefylline has the following structural formula. Istradefylline is a light yellow-green crystalline powder. Istradefylline has a dissociation constant (pKa) of 0.78. The aqueous solubility of istradefylline is ~0.5 µg/mL across the physiological pH range and 0.6 µg/mL in water. NOURIANZ tablets are intended for oral administration only. Each tablet contains 20 mg or 40 mg of istradefylline and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinyl alcohol. The film coating contains hypromellose, lactose monohydrate, polyethylene glycol 3350, titanium dioxide, triacetin, and the following dyes: iron oxide red and iron oxide yellow. Carnauba wax is used for polishing.</Description>
</NDC>
<NDC>
<NDCCode>43547-602-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (43547-602-10) </PackageDescription>
<NDC11Code>43547-0602-10</NDC11Code>
<ProductNDC>43547-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine Dimesylate Capsules</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230826</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216266</ApplicationNumber>
<LabelerName>Solco Healthcare US,LLC</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]., 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate capsules, a CNS stimulant, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino‑N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical structure is. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The imprinting ink for all strengths contain D&C yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, iron oxide black, potassium hydroxide, propylene glycol and shellac glaze. The capsule shells of each strength contain ingredients as below.</Description>
</NDC>
<NDC>
<NDCCode>51655-602-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (51655-602-20) </PackageDescription>
<NDC11Code>51655-0602-20</NDC11Code>
<ProductNDC>51655-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metaxalone</ProprietaryName>
<NonProprietaryName>Metaxalone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208774</ApplicationNumber>
<LabelerName>Northwind Pharmaceuticals</LabelerName>
<SubstanceName>METAXALONE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Metaxalone tablets, USP are available as an 800 mg oval, scored pink tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C 12H 15NO 3, which corresponds to a molecular weight of 221.25. The structural formula is:. Metaxalone is a white crystalline powder, soluble in chloroform, acetonitrile and methanol, but insoluble in water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: anhydrous citric acid, FD&C Red # 40, sodium alginate and magnesium stearate. USP Dissolution Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>60951-602-70</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (60951-602-70) </PackageDescription>
<NDC11Code>60951-0602-70</NDC11Code>
<ProductNDC>60951-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Endocet</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000526</StartMarketingDate>
<EndMarketingDate>20270331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040330</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20000526</StartMarketingDatePackage>
<EndMarketingDatePackage>20270331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>60951-602-85</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (60951-602-85) </PackageDescription>
<NDC11Code>60951-0602-85</NDC11Code>
<ProductNDC>60951-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Endocet</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000526</StartMarketingDate>
<EndMarketingDate>20270331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040330</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20000526</StartMarketingDatePackage>
<EndMarketingDatePackage>20261031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>64980-602-03</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (64980-602-03) </PackageDescription>
<NDC11Code>64980-0602-03</NDC11Code>
<ProductNDC>64980-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208659</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablet are indicated for the treatment of hypertension, in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil USP is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets USP is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil USP and the following inactive ingredients: hydroxy propyl cellulose, hypromellose, lactose monohydrate, low substituted HPC, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and yellow iron oxide (5 mg only).</Description>
</NDC>
<NDC>
<NDCCode>64980-602-09</NDCCode>
<PackageDescription>90 TABLET, COATED in 1 BOTTLE (64980-602-09) </PackageDescription>
<NDC11Code>64980-0602-09</NDC11Code>
<ProductNDC>64980-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208659</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablet are indicated for the treatment of hypertension, in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil USP is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil USP is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Olmesartan medoxomil tablets USP is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil USP and the following inactive ingredients: hydroxy propyl cellulose, hypromellose, lactose monohydrate, low substituted HPC, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and yellow iron oxide (5 mg only).</Description>
</NDC>
<NDC>
<NDCCode>66312-602-16</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (66312-602-16) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>66312-0602-16</NDC11Code>
<ProductNDC>66312-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Articadent</ProprietaryName>
<NonProprietaryName>Articaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020971</ApplicationNumber>
<LabelerName>Dentsply Pharmaceutical</LabelerName>
<SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .005</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
<Description>ARTICADENT (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength. Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. ARTICADENT contains the following inactive ingredients: sodium chloride (1.6 mg/mL), and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>66336-602-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (66336-602-30)</PackageDescription>
<NDC11Code>66336-0602-30</NDC11Code>
<ProductNDC>66336-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075991</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin is indicated to reduce the risk of: : 1 Myocardial infarction , 2 Unstable angina , 3 Coronary revascularization procedures .</IndicationAndUsage>
<Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1 S -[1α(R *), 3α, 7β, 8β(2 S *,4 S *),8aβ]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C 24 H 36 O 5 and its molecular weight is 404.55. Its structural formula is:. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin tablets are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, pregelatinized starch, sodium starch glycolate, butylated hydroxyaniso and talc. Butylated hydroxyanisole (BHA) is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>68083-602-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68083-602-01) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68083-0602-01</NDC11Code>
<ProductNDC>68083-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Travoprost Ophthalmic Solution</ProprietaryName>
<NonProprietaryName>Travoprost Ophthalmic Solution</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218159</ApplicationNumber>
<LabelerName>Gland Pharma Limited</LabelerName>
<SubstanceName>TRAVOPROST</SubstanceName>
<StrengthNumber>.04</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.</IndicationAndUsage>
<Description>Travoprost is a synthetic prostaglandin F analog. Its chemical name is [1R-[1α(Z),2β(1E,3R*),3α,5α]]-7-[3,5-Dihydroxy-2-[3-hydroxy-4-[3-(trifluoromethyl) phenoxy]-1-butenyl]cyclopentyl]-5-heptenoic acid, 1-methylethylester. It has a molecular formula of C26H35F3O6 and a molecular weight of 500.55 g/mol. The chemical structure of travoprost is. Travoprost, USP is a clear, colorless and viscous oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. It is practically insoluble in water. Travoprost ophthalmic solution, USP (ionic buffered solution) 0.004% is supplied as sterile, buffered aqueous solution of travoprost with a pH of approximately 5.7 and an osmolality of approximately 290 mOsmol/kg. Travoprost ophthalmic solution, USP (ionic buffered solution) 0.004% contains Active: travoprost, USP 0.04 mg/mL; Inactives: polyoxyl 40 hydrogenated castor oil, boric acid, propylene glycol, sorbitol, zinc chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. Preserved in the bottle with an ionic buffered system.</Description>
</NDC>
<NDC>
<NDCCode>69292-602-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (69292-602-01) </PackageDescription>
<NDC11Code>69292-0602-01</NDC11Code>
<ProductNDC>69292-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075584</ApplicationNumber>
<LabelerName>Amici Pharma, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride tablets, USP are supplied for oral administration as 75-mg and 100-mg lavender film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients. FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, hypromellose, microcrystalline cellulose, potassium chloride, pregelatinized starch, stearic acid, titanium dioxide, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>71205-602-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-602-30) </PackageDescription>
<NDC11Code>71205-0602-30</NDC11Code>
<ProductNDC>71205-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208706</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending.</Description>
</NDC>
<NDC>
<NDCCode>71205-602-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-602-60) </PackageDescription>
<NDC11Code>71205-0602-60</NDC11Code>
<ProductNDC>71205-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208706</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending.</Description>
</NDC>
<NDC>
<NDCCode>71205-602-90</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-602-90) </PackageDescription>
<NDC11Code>71205-0602-90</NDC11Code>
<ProductNDC>71205-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208706</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending.</Description>
</NDC>
<NDC>
<NDCCode>75854-602-02</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (75854-602-02) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>75854-0602-02</NDC11Code>
<ProductNDC>75854-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Balcoltra</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180410</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208612</ApplicationNumber>
<LabelerName>Avion Pharmaceuticals</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound. 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate. The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch. Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake. Levonorgestrel has the empirical formula of C21H28O2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C20H24O2 and the molecular weight of 296.4. The molecular structures are provided below.</Description>
</NDC>
<NDC>
<NDCCode>75854-602-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (75854-602-03) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>75854-0602-03</NDC11Code>
<ProductNDC>75854-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Balcoltra</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180410</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208612</ApplicationNumber>
<LabelerName>Avion Pharmaceuticals</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound. 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate. The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch. Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake. Levonorgestrel has the empirical formula of C21H28O2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C20H24O2 and the molecular weight of 296.4. The molecular structures are provided below.</Description>
</NDC>
<NDC>
<NDCCode>75854-602-28</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (75854-602-28) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>75854-0602-28</NDC11Code>
<ProductNDC>75854-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Balcoltra</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180410</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208612</ApplicationNumber>
<LabelerName>Avion Pharmaceuticals</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets. 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound. 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate. The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch. Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake. Levonorgestrel has the empirical formula of C21H28O2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C20H24O2 and the molecular weight of 296.4. The molecular structures are provided below.</Description>
</NDC>
<NDC>
<NDCCode>81877-602-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, GLASS (81877-602-04) </PackageDescription>
<NDC11Code>81877-0602-04</NDC11Code>
<ProductNDC>81877-602</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Methyl Salicylate 40% Topical Oil</ProprietaryName>
<NonProprietaryName>Methyl Salicylate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>FORREAL PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52763-101-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52763-101-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>52763-0101-60</NDC11Code>
<ProductNDC>52763-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocream 10</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150505</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>Golden Touch LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses For the temporary relief of pain and itching due to anorectal disorders.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52763-401-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52763-401-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>52763-0401-30</NDC11Code>
<ProductNDC>52763-401</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocream 4</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>Golden Touch LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the temporary relief of pain and itching due to: 1 minor burns, 2 minor skin irritations, 3 minor cuts, 4 scrapes, 5 sunburn, 6 insect bites.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52763-401-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52763-401-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>52763-0401-60</NDC11Code>
<ProductNDC>52763-401</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocream 4</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>Golden Touch LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the temporary relief of pain and itching due to: 1 minor burns, 2 minor skin irritations.</IndicationAndUsage>
</NDC>
</NDCList>