{
"NDC": [
{
"NDCCode": "0268-0807-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0807-50) ",
"NDC11Code": "00268-0807-50",
"ProductNDC": "0268-0807",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Alternaria Tenuis",
"NonProprietaryName": "Alternaria Tenuis",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"EndMarketingDate": "20211130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "ALTERNARIA ALTERNATA",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19650101",
"EndMarketingDatePackage": "20211130",
"SamplePackage": "N"
},
{
"NDCCode": "0268-0807-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-0807-10) ",
"NDC11Code": "00268-0807-10",
"ProductNDC": "0268-0807",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Alternaria Tenuis",
"NonProprietaryName": "Alternaria Tenuis",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"EndMarketingDate": "20211130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "ALTERNARIA ALTERNATA",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19650101",
"EndMarketingDatePackage": "20211130",
"SamplePackage": "N"
},
{
"NDCCode": "21749-807-50",
"PackageDescription": "189271 mL in 1 PACKAGE (21749-807-50) ",
"NDC11Code": "21749-0807-50",
"ProductNDC": "21749-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purell Advanced Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110411",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200824",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin that could cause disease."
},
{
"NDCCode": "65162-807-50",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (65162-807-50) ",
"NDC11Code": "65162-0807-50",
"ProductNDC": "65162-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Progesterone",
"NonProprietaryName": "Progesterone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207724",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170911",
"SamplePackage": "N",
"IndicationAndUsage": "Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.",
"Description": "Progesterone capsules contain progesterone, USP for oral administration. Progesterone, USP has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone, USP (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is:. Progesterone, USP is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain either 100 mg or 200 mg progesterone, USP. The inactive ingredients for progesterone capsules 100 mg and 200 mg include: arachis oil, D&C Yellow No. 10 aluminum lake, FD&C Yellow No. 6 aluminum lake, gelatin, glycerin, purified water, soy lecithin and titanium dioxide."
},
{
"NDCCode": "75600-807-50",
"PackageDescription": "1 mL in 1 BOTTLE, PLASTIC (75600-807-50) ",
"NDC11Code": "75600-0807-50",
"ProductNDC": "75600-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "CLASSIC WINE VINEGAR COMPANY INC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0406-0807-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0807-01) ",
"NDC11Code": "00406-0807-01",
"ProductNDC": "0406-0807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mixed Salts Of A Single-entity Amphetamine Product",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20231101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211546",
"LabelerName": "SpecGx LLC",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE",
"StrengthNumber": "9.375; 9.375; 9.375; 9.375",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14)]. Limitations of Use:Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite [see Use in Specific Populations (8.4)].",
"Description": "Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate and amphetamine sulfate, dextroamphetamine saccharate and amphetamine aspartate monohydrate. This results in a 3:1 mixture of dextro- to levoamphetamine base equivalent. The 12.5 mg, 25 mg, 37.5 mg and 50 mg strength capsules are for oral administration. They contain three types of drug-releasing beads, an immediate release and two different types of delayed release (DR) beads. The first DR bead releases amphetamine at pH 5.5 and the other DR bead releases amphetamine at pH 7.0. Inactive Ingredients and Colors: The inactive ingredients in Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules include: hard gelatin capsules, ethylcellulose, medium-chain triglycerides, oleic acid, hydroxypropyl cellulose, magnesium stearate, Methacrylic Acid and Ethyl Acrylate Copolymer, sodium lauryl sulfate, polysorbate, sucrose, corn starch, talc, triethyl citrate, and (poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid 7:3:1; 280000 mw)). The gelatin capsules for all four strengths contain gelatin, Sodium lauryl sulfate, titanium dioxide, and edible inks which contain shellac glaze, propylene glycol, potassium hydroxide, and black iron oxide. The 12.5 mg strength gelatin capsules also contain yellow iron oxide. The 37.5 mg strength contains FD&C Blue No. 1 and FD&C Red No. 3. The 50 mg strength capsule also contains FD&C Blue No. 1."
},
{
"NDCCode": "23155-807-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (23155-807-01) ",
"NDC11Code": "23155-0807-01",
"ProductNDC": "23155-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213590",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230625",
"SamplePackage": "N",
"IndicationAndUsage": "For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.",
"Description": "Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride occurs as white or slightly creamy white, odorless, crystalline powder which darkens on prolonged exposure to light. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine HCl, USP. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, and magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide. For 10 mg and 25 mg tablets, FD&C Blue #2 aluminum lake. For 50 mg tablets, FD&C Yellow #6 aluminum lake, and ferric oxide red. For 100 mg and 200 mg tablets, D&C Red #7 lake and FD&C Blue #2 aluminum lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "50090-0807-0",
"PackageDescription": "240 TABLET in 1 BOTTLE (50090-0807-0) ",
"NDC11Code": "50090-0807-00",
"ProductNDC": "50090-0807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075964",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80."
},
{
"NDCCode": "50090-0807-1",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-0807-1) ",
"NDC11Code": "50090-0807-01",
"ProductNDC": "50090-0807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075964",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80."
},
{
"NDCCode": "50090-0807-2",
"PackageDescription": "10 TABLET in 1 BOTTLE (50090-0807-2) ",
"NDC11Code": "50090-0807-02",
"ProductNDC": "50090-0807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075964",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80."
},
{
"NDCCode": "50090-0807-3",
"PackageDescription": "180 TABLET in 1 BOTTLE (50090-0807-3) ",
"NDC11Code": "50090-0807-03",
"ProductNDC": "50090-0807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075964",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80."
},
{
"NDCCode": "50090-0807-4",
"PackageDescription": "40 TABLET in 1 BOTTLE (50090-0807-4) ",
"NDC11Code": "50090-0807-04",
"ProductNDC": "50090-0807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075964",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20140815",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80."
},
{
"NDCCode": "50090-0807-5",
"PackageDescription": "21 TABLET in 1 BOTTLE (50090-0807-5) ",
"NDC11Code": "50090-0807-05",
"ProductNDC": "50090-0807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075964",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20140815",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80."
},
{
"NDCCode": "50090-0807-6",
"PackageDescription": "28 TABLET in 1 BOTTLE (50090-0807-6) ",
"NDC11Code": "50090-0807-06",
"ProductNDC": "50090-0807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075964",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20140815",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80."
},
{
"NDCCode": "50268-807-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-807-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-807-11) ",
"NDC11Code": "50268-0807-15",
"ProductNDC": "50268-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078235",
"LabelerName": "AvPAK",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260608",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white crystalline powder with bitter taste. It is freely soluble in dichloromethane. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Each topiramate tablet,USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 200 mg of topiramate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Each topiramate capsule, USP intended for oral administration contains 15 mg or 25 mg or 50 mg of topiramate. In addition, each capsule contains the following inactive ingredients: cellulose acetate, gelatin, hypromellose, povidone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and water. Each capsule is printed with black pharmaceutical ink and contains the following inactive ingredients: shellac, propylene glycol, black iron oxide and potassium hydroxide. Topiramate Capsules, USP meet USP dissolution test 2."
},
{
"NDCCode": "50383-807-12",
"PackageDescription": "10 TRAY in 1 CASE (50383-807-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-807-10) ",
"NDC11Code": "50383-0807-12",
"ProductNDC": "50383-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amantadine Hydrochloride",
"NonProprietaryName": "Amantadine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19941028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074170",
"LabelerName": "Akorn",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-05-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140604",
"SamplePackage": "N"
},
{
"NDCCode": "50383-807-16",
"PackageDescription": "473 mL in 1 BOTTLE (50383-807-16) ",
"NDC11Code": "50383-0807-16",
"ProductNDC": "50383-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amantadine Hydrochloride",
"NonProprietaryName": "Amantadine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19941028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074170",
"LabelerName": "Akorn",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19941028",
"SamplePackage": "N",
"IndicationAndUsage": "Amantadine hydrochloride is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride is also indicated in the treatment of parkinsonism and druginduced extrapyramidal reactions.",
"Description": "Amantadine Hydrochloride, USP is designated generically as amantadine hydrochloride and chemically as 1- adamantanamine hydrochloride. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride oral solution contains 50 mg of amantadine hydrochloride per 5 mL and has the following inactive ingredients: artificial raspberry flavor, citric acid, methylparaben, propylparaben, purified water, and sorbitol solution."
},
{
"NDCCode": "50844-807-15",
"PackageDescription": "1 BOTTLE in 1 CARTON (50844-807-15) > 50 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "50844-0807-15",
"ProductNDC": "50844-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Headache Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen, Aspirin, Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19921117",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "L.N.K. International, Inc.",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "19921117",
"SamplePackage": "N"
},
{
"NDCCode": "51706-807-01",
"PackageDescription": "50 mL in 1 BOTTLE (51706-807-01) ",
"NDC11Code": "51706-0807-01",
"ProductNDC": "51706-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitiser Foam",
"NonProprietaryName": "Benzalonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Landy International",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "13",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N"
},
{
"NDCCode": "58232-0807-3",
"PackageDescription": "85 g in 1 TUBE (58232-0807-3)",
"NDC11Code": "58232-0807-03",
"ProductNDC": "58232-0807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aveeno Protect Plus Hydrate Sunscreen",
"ProprietaryNameSuffix": "Broad Spectrum Spf50",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120412",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 100; 50; 60; 50",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2015-12-25"
},
{
"NDCCode": "58411-807-60",
"PackageDescription": "1 TUBE in 1 CARTON (58411-807-60) > 50 mL in 1 TUBE",
"NDC11Code": "58411-0807-60",
"ProductNDC": "58411-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laura Mercier Tinted Moisturizer Natural Skin Perfector Broad Spectrum Spf 30 Sunscreen",
"ProprietaryNameSuffix": "1w1 Porcelain",
"NonProprietaryName": "Avobenzone, Octinoxate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211130",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Laura Mercier Cosmetics",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "1.25; 3.745; 1; .5",
"StrengthUnit": "g/50mL; g/50mL; g/50mL; g/50mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20211130",
"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": "59078-807-01",
"PackageDescription": "50 mL in 1 BOTTLE (59078-807-01) ",
"NDC11Code": "59078-0807-01",
"ProductNDC": "59078-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aloe Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "TONYMOLY CO., LTD.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand gel that kills germs that can potentially cause disease."
},
{
"NDCCode": "59088-807-00",
"PackageDescription": "1 KIT in 1 KIT (59088-807-00) * 15 POUCH in 1 CARTON (59088-396-82) / .7 g in 1 POUCH",
"NDC11Code": "59088-0807-00",
"ProductNDC": "59088-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacinrx Phn Pak",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "KIT",
"StartMarketingDate": "20160517",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160517",
"SamplePackage": "N",
"IndicationAndUsage": "HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Lidocaine patch 5% safely and effectively. See full prescribing information for Lidocaine patch 5%. Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin. Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: glycerin, D-sorbitol, propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium, gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, and edetate disodium."
},
{
"NDCCode": "59651-807-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (59651-807-01) ",
"NDC11Code": "59651-0807-01",
"ProductNDC": "59651-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202640",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2023-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230914",
"SamplePackage": "N",
"IndicationAndUsage": "Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.",
"Description": "Meclizine hydrochloride, USP a histamine (H1) receptor antagonist, is a white to slight yellowish crystalline powder. It has the following structural formula. Chemically, meclizine hydrochloride is 1-(p-Chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Tablets: Inactive ingredients for the tablets are: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to. 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to. 21.07 mg of meclizine free base. Each meclizine hydrochloride 50 mg tablet contains 50 mg of meclizine dihydrochloride equivalent to 42.14 mg of meclizine free base."
},
{
"NDCCode": "59651-807-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59651-807-99) ",
"NDC11Code": "59651-0807-99",
"ProductNDC": "59651-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202640",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2023-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230914",
"SamplePackage": "N",
"IndicationAndUsage": "Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.",
"Description": "Meclizine hydrochloride, USP a histamine (H1) receptor antagonist, is a white to slight yellowish crystalline powder. It has the following structural formula. Chemically, meclizine hydrochloride is 1-(p-Chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Tablets: Inactive ingredients for the tablets are: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to. 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to. 21.07 mg of meclizine free base. Each meclizine hydrochloride 50 mg tablet contains 50 mg of meclizine dihydrochloride equivalent to 42.14 mg of meclizine free base."
},
{
"NDCCode": "60846-807-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (60846-807-01) ",
"NDC11Code": "60846-0807-01",
"ProductNDC": "60846-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Unithroid",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140703",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021210",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140703",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. UNITHROID is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. UNITHROID is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 UNITHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with UNITHROID may induce hyperthyroidism [see Warnings and Precautions (5.4)]., 2 UNITHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "UNITHROID contains the active ingredient, levothyroxine, a synthetic crystalline levothyroxine (T4) in sodium salt form. It is chemically designated as L-3,3’,5,5’-tetraiodothyronine monosodium hydrate. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.85 g/mol (anhydrous), and structural formula as shown. UNITHROID tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Inactive Ingredients. Acacia, colloidal silicon dioxide, corn starch, lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The following are the coloring additives per tablet strength."
},
{
"NDCCode": "62839-0807-1",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (62839-0807-1) > 30 mL in 1 BOTTLE, PUMP",
"NDC11Code": "62839-0807-01",
"ProductNDC": "62839-0807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nu Skin Nu Colour",
"ProprietaryNameSuffix": "Moisturshade Finish Spf 15 Sunset Beige",
"NonProprietaryName": "Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110103",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NSE Products, Inc.",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": "50; 20; 30; 65.22",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "65862-807-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (65862-807-05) ",
"NDC11Code": "65862-0807-05",
"ProductNDC": "65862-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206069",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
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"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of UseIn OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in methanol and in acetone, slightly soluble in ethanol and practically insoluble in water. Armodafinil tablets contain 50 mg, 150 mg, 200 mg, and 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and povidone."
},
{
"NDCCode": "65862-807-30",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of UseIn OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in methanol and in acetone, slightly soluble in ethanol and practically insoluble in water. Armodafinil tablets contain 50 mg, 150 mg, 200 mg, and 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and povidone."
},
{
"NDCCode": "65862-807-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (65862-807-60) ",
"NDC11Code": "65862-0807-60",
"ProductNDC": "65862-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206069",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "250",
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"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of UseIn OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in methanol and in acetone, slightly soluble in ethanol and practically insoluble in water. Armodafinil tablets contain 50 mg, 150 mg, 200 mg, and 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and povidone."
}
]
}
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<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (0268-0807-50) </PackageDescription>
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<Status>Deprecated</Status>
<LastUpdate>2021-12-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19650101</StartMarketingDatePackage>
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<NDC11Code>00268-0807-10</NDC11Code>
<ProductNDC>0268-0807</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Alternaria Tenuis</ProprietaryName>
<NonProprietaryName>Alternaria Tenuis</NonProprietaryName>
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<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<EndMarketingDate>20211130</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
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<LastUpdate>2021-12-01</LastUpdate>
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<StartMarketingDatePackage>19650101</StartMarketingDatePackage>
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<NDCCode>21749-807-50</NDCCode>
<PackageDescription>189271 mL in 1 PACKAGE (21749-807-50) </PackageDescription>
<NDC11Code>21749-0807-50</NDC11Code>
<ProductNDC>21749-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purell Advanced Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110411</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin that could cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65162-807-50</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (65162-807-50) </PackageDescription>
<NDC11Code>65162-0807-50</NDC11Code>
<ProductNDC>65162-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Progesterone</ProprietaryName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207724</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.</IndicationAndUsage>
<Description>Progesterone capsules contain progesterone, USP for oral administration. Progesterone, USP has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone, USP (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is:. Progesterone, USP is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain either 100 mg or 200 mg progesterone, USP. The inactive ingredients for progesterone capsules 100 mg and 200 mg include: arachis oil, D&C Yellow No. 10 aluminum lake, FD&C Yellow No. 6 aluminum lake, gelatin, glycerin, purified water, soy lecithin and titanium dioxide.</Description>
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<NDC>
<NDCCode>75600-807-50</NDCCode>
<PackageDescription>1 mL in 1 BOTTLE, PLASTIC (75600-807-50) </PackageDescription>
<NDC11Code>75600-0807-50</NDC11Code>
<ProductNDC>75600-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>CLASSIC WINE VINEGAR COMPANY INC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0406-0807-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0807-01) </PackageDescription>
<NDC11Code>00406-0807-01</NDC11Code>
<ProductNDC>0406-0807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mixed Salts Of A Single-entity Amphetamine Product</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211546</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>9.375; 9.375; 9.375; 9.375</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14)]. Limitations of Use:Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite [see Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate and amphetamine sulfate, dextroamphetamine saccharate and amphetamine aspartate monohydrate. This results in a 3:1 mixture of dextro- to levoamphetamine base equivalent. The 12.5 mg, 25 mg, 37.5 mg and 50 mg strength capsules are for oral administration. They contain three types of drug-releasing beads, an immediate release and two different types of delayed release (DR) beads. The first DR bead releases amphetamine at pH 5.5 and the other DR bead releases amphetamine at pH 7.0. Inactive Ingredients and Colors: The inactive ingredients in Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules include: hard gelatin capsules, ethylcellulose, medium-chain triglycerides, oleic acid, hydroxypropyl cellulose, magnesium stearate, Methacrylic Acid and Ethyl Acrylate Copolymer, sodium lauryl sulfate, polysorbate, sucrose, corn starch, talc, triethyl citrate, and (poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid 7:3:1; 280000 mw)). The gelatin capsules for all four strengths contain gelatin, Sodium lauryl sulfate, titanium dioxide, and edible inks which contain shellac glaze, propylene glycol, potassium hydroxide, and black iron oxide. The 12.5 mg strength gelatin capsules also contain yellow iron oxide. The 37.5 mg strength contains FD&C Blue No. 1 and FD&C Red No. 3. The 50 mg strength capsule also contains FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>23155-807-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (23155-807-01) </PackageDescription>
<NDC11Code>23155-0807-01</NDC11Code>
<ProductNDC>23155-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213590</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.</IndicationAndUsage>
<Description>Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride occurs as white or slightly creamy white, odorless, crystalline powder which darkens on prolonged exposure to light. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine HCl, USP. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, and magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide. For 10 mg and 25 mg tablets, FD&C Blue #2 aluminum lake. For 50 mg tablets, FD&C Yellow #6 aluminum lake, and ferric oxide red. For 100 mg and 200 mg tablets, D&C Red #7 lake and FD&C Blue #2 aluminum lake. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>50090-0807-0</NDCCode>
<PackageDescription>240 TABLET in 1 BOTTLE (50090-0807-0) </PackageDescription>
<NDC11Code>50090-0807-00</NDC11Code>
<ProductNDC>50090-0807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075964</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>50090-0807-1</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-0807-1) </PackageDescription>
<NDC11Code>50090-0807-01</NDC11Code>
<ProductNDC>50090-0807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075964</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>50090-0807-2</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (50090-0807-2) </PackageDescription>
<NDC11Code>50090-0807-02</NDC11Code>
<ProductNDC>50090-0807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075964</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>50090-0807-3</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (50090-0807-3) </PackageDescription>
<NDC11Code>50090-0807-03</NDC11Code>
<ProductNDC>50090-0807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075964</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>50090-0807-4</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (50090-0807-4) </PackageDescription>
<NDC11Code>50090-0807-04</NDC11Code>
<ProductNDC>50090-0807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075964</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>50090-0807-5</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE (50090-0807-5) </PackageDescription>
<NDC11Code>50090-0807-05</NDC11Code>
<ProductNDC>50090-0807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075964</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>50090-0807-6</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (50090-0807-6) </PackageDescription>
<NDC11Code>50090-0807-06</NDC11Code>
<ProductNDC>50090-0807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075964</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>50268-807-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-807-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-807-11) </PackageDescription>
<NDC11Code>50268-0807-15</NDC11Code>
<ProductNDC>50268-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078235</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white crystalline powder with bitter taste. It is freely soluble in dichloromethane. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Each topiramate tablet,USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 200 mg of topiramate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Each topiramate capsule, USP intended for oral administration contains 15 mg or 25 mg or 50 mg of topiramate. In addition, each capsule contains the following inactive ingredients: cellulose acetate, gelatin, hypromellose, povidone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and water. Each capsule is printed with black pharmaceutical ink and contains the following inactive ingredients: shellac, propylene glycol, black iron oxide and potassium hydroxide. Topiramate Capsules, USP meet USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>50383-807-12</NDCCode>
<PackageDescription>10 TRAY in 1 CASE (50383-807-12) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-807-10) </PackageDescription>
<NDC11Code>50383-0807-12</NDC11Code>
<ProductNDC>50383-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amantadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19941028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074170</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-807-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (50383-807-16) </PackageDescription>
<NDC11Code>50383-0807-16</NDC11Code>
<ProductNDC>50383-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amantadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19941028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074170</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19941028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amantadine hydrochloride is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride is also indicated in the treatment of parkinsonism and druginduced extrapyramidal reactions.</IndicationAndUsage>
<Description>Amantadine Hydrochloride, USP is designated generically as amantadine hydrochloride and chemically as 1- adamantanamine hydrochloride. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride oral solution contains 50 mg of amantadine hydrochloride per 5 mL and has the following inactive ingredients: artificial raspberry flavor, citric acid, methylparaben, propylparaben, purified water, and sorbitol solution.</Description>
</NDC>
<NDC>
<NDCCode>50844-807-15</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50844-807-15) > 50 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>50844-0807-15</NDC11Code>
<ProductNDC>50844-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Headache Relief</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin, Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19921117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>L.N.K. International, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19921117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51706-807-01</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (51706-807-01) </PackageDescription>
<NDC11Code>51706-0807-01</NDC11Code>
<ProductNDC>51706-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitiser Foam</ProprietaryName>
<NonProprietaryName>Benzalonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Landy International</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58232-0807-3</NDCCode>
<PackageDescription>85 g in 1 TUBE (58232-0807-3)</PackageDescription>
<NDC11Code>58232-0807-03</NDC11Code>
<ProductNDC>58232-0807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aveeno Protect Plus Hydrate Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf50</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120412</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 100; 50; 60; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-12-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>58411-807-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-807-60) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0807-60</NDC11Code>
<ProductNDC>58411-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laura Mercier Tinted Moisturizer Natural Skin Perfector Broad Spectrum Spf 30 Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>1w1 Porcelain</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octinoxate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Laura Mercier Cosmetics</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>1.25; 3.745; 1; .5</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211130</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>59078-807-01</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (59078-807-01) </PackageDescription>
<NDC11Code>59078-0807-01</NDC11Code>
<ProductNDC>59078-807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aloe Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>TONYMOLY CO., LTD.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand gel that kills germs that can potentially cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-807-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-807-00) * 15 POUCH in 1 CARTON (59088-396-82) / .7 g in 1 POUCH</PackageDescription>
<NDC11Code>59088-0807-00</NDC11Code>
<ProductNDC>59088-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dermacinrx Phn Pak</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Lidocaine patch 5% safely and effectively. See full prescribing information for Lidocaine patch 5%. Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin. Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: glycerin, D-sorbitol, propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium, gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, and edetate disodium.</Description>
</NDC>
<NDC>
<NDCCode>59651-807-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (59651-807-01) </PackageDescription>
<NDC11Code>59651-0807-01</NDC11Code>
<ProductNDC>59651-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202640</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
<Description>Meclizine hydrochloride, USP a histamine (H1) receptor antagonist, is a white to slight yellowish crystalline powder. It has the following structural formula. Chemically, meclizine hydrochloride is 1-(p-Chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Tablets: Inactive ingredients for the tablets are: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to. 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to. 21.07 mg of meclizine free base. Each meclizine hydrochloride 50 mg tablet contains 50 mg of meclizine dihydrochloride equivalent to 42.14 mg of meclizine free base.</Description>
</NDC>
<NDC>
<NDCCode>59651-807-99</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (59651-807-99) </PackageDescription>
<NDC11Code>59651-0807-99</NDC11Code>
<ProductNDC>59651-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202640</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
<Description>Meclizine hydrochloride, USP a histamine (H1) receptor antagonist, is a white to slight yellowish crystalline powder. It has the following structural formula. Chemically, meclizine hydrochloride is 1-(p-Chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Tablets: Inactive ingredients for the tablets are: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to. 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to. 21.07 mg of meclizine free base. Each meclizine hydrochloride 50 mg tablet contains 50 mg of meclizine dihydrochloride equivalent to 42.14 mg of meclizine free base.</Description>
</NDC>
<NDC>
<NDCCode>60846-807-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (60846-807-01) </PackageDescription>
<NDC11Code>60846-0807-01</NDC11Code>
<ProductNDC>60846-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Unithroid</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140703</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021210</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. UNITHROID is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. UNITHROID is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 UNITHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with UNITHROID may induce hyperthyroidism [see Warnings and Precautions (5.4)]., 2 UNITHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>UNITHROID contains the active ingredient, levothyroxine, a synthetic crystalline levothyroxine (T4) in sodium salt form. It is chemically designated as L-3,3’,5,5’-tetraiodothyronine monosodium hydrate. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.85 g/mol (anhydrous), and structural formula as shown. UNITHROID tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Inactive Ingredients. Acacia, colloidal silicon dioxide, corn starch, lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The following are the coloring additives per tablet strength.</Description>
</NDC>
<NDC>
<NDCCode>62839-0807-1</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (62839-0807-1) > 30 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>62839-0807-01</NDC11Code>
<ProductNDC>62839-0807</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nu Skin Nu Colour</ProprietaryName>
<ProprietaryNameSuffix>Moisturshade Finish Spf 15 Sunset Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110103</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NSE Products, Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>50; 20; 30; 65.22</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65862-807-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (65862-807-05) </PackageDescription>
<NDC11Code>65862-0807-05</NDC11Code>
<ProductNDC>65862-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206069</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of UseIn OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in methanol and in acetone, slightly soluble in ethanol and practically insoluble in water. Armodafinil tablets contain 50 mg, 150 mg, 200 mg, and 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>65862-807-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (65862-807-30) </PackageDescription>
<NDC11Code>65862-0807-30</NDC11Code>
<ProductNDC>65862-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206069</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of UseIn OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in methanol and in acetone, slightly soluble in ethanol and practically insoluble in water. Armodafinil tablets contain 50 mg, 150 mg, 200 mg, and 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>65862-807-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (65862-807-60) </PackageDescription>
<NDC11Code>65862-0807-60</NDC11Code>
<ProductNDC>65862-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206069</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of UseIn OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in methanol and in acetone, slightly soluble in ethanol and practically insoluble in water. Armodafinil tablets contain 50 mg, 150 mg, 200 mg, and 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and povidone.</Description>
</NDC>
</NDCList>