{
"NDC": [
{
"NDCCode": "35573-466-02",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-466-02) ",
"NDC11Code": "35573-0466-02",
"ProductNDC": "35573-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191216",
"EndMarketingDate": "20280229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212037",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE",
"StrengthNumber": "3.75; 3.75; 3.75; 3.75",
"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": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191216",
"EndMarketingDatePackage": "20280229",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).",
"Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac."
},
{
"NDCCode": "43333-466-02",
"PackageDescription": "59 mL in 1 BOTTLE, DISPENSING (43333-466-02) ",
"NDC11Code": "43333-0466-02",
"ProductNDC": "43333-466",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"EndMarketingDate": "20220330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Tonic Bath & Body Products Shenzhen Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200407",
"EndMarketingDatePackage": "20220330",
"SamplePackage": "N"
},
{
"NDCCode": "50844-466-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (50844-466-02) > 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50844-0466-02",
"ProductNDC": "50844-466",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinus Congestion And Pain",
"ProprietaryNameSuffix": "Daytime",
"NonProprietaryName": "Acetaminophen And Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050726",
"EndMarketingDate": "20190810",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "L.N.K. International, Inc.",
"SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 5",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-08-13",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "51346-466-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (51346-466-02) > 13 g in 1 CONTAINER (51346-466-01)",
"NDC11Code": "51346-0466-02",
"ProductNDC": "51346-466",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Provence Air Skin Fit Oi L Control Bb Cushion 02 Natural Beige",
"NonProprietaryName": "Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "1.24; 1.24; .91; .58",
"StrengthUnit": "g/13g; g/13g; g/13g; g/13g",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "52125-466-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-466-02)",
"NDC11Code": "52125-0466-02",
"ProductNDC": "52125-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130522",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018413",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-13"
},
{
"NDCCode": "54575-466-02",
"PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (54575-466-02)",
"NDC11Code": "54575-0466-02",
"ProductNDC": "54575-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tomato",
"NonProprietaryName": "Tomato",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "TOMATO",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
},
{
"NDCCode": "61786-466-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (61786-466-02)",
"NDC11Code": "61786-0466-02",
"ProductNDC": "61786-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078154",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-04-04"
},
{
"NDCCode": "63323-466-31",
"PackageDescription": "5 VIAL, SINGLE-DOSE in 1 BOX (63323-466-31) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-466-02) ",
"NDC11Code": "63323-0466-31",
"ProductNDC": "63323-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sensorcaine",
"ProprietaryNameSuffix": "Mpf",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20101119",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018304",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101119",
"SamplePackage": "N",
"IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. (See DOSAGE AND ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
"Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure:. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula:. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage."
},
{
"NDCCode": "63545-466-02",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (63545-466-02) ",
"NDC11Code": "63545-0466-02",
"ProductNDC": "63545-466",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carum Carvi",
"NonProprietaryName": "Carum Carvi",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220511",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "CARAWAY SEED",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220511",
"SamplePackage": "N"
},
{
"NDCCode": "67209-466-02",
"PackageDescription": "10 CARTON in 1 BOX (67209-466-02) > 10 BOTTLE in 1 CARTON > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "67209-0466-02",
"ProductNDC": "67209-466",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"StartMarketingDate": "20100927",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "WellSpring Pharma Services Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "69085-466-02",
"PackageDescription": "45 g in 1 TUBE (69085-466-02) ",
"NDC11Code": "69085-0466-02",
"ProductNDC": "69085-466",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Omnicide Antimicrobial",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140702",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SteriWeb Medical, LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140702",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help treat, protect and prevent skin infection associated with: 1 minor cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "69423-466-02",
"PackageDescription": "3 CARTON in 1 CELLO PACK (69423-466-02) / 1 JAR in 1 CARTON / 48 g in 1 JAR",
"NDC11Code": "69423-0466-02",
"ProductNDC": "69423-466",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Olay Regenerist Whip Moisturizer Broad Spectrum Spf 25 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 8; 4; 5",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230130",
"EndMarketingDatePackage": "20250301",
"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": "72888-466-02",
"PackageDescription": "237 mL in 1 BOTTLE (72888-466-02) ",
"NDC11Code": "72888-0466-02",
"ProductNDC": "72888-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214445",
"LabelerName": "Advagen Pharma Ltd.,",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250603",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen oral solution is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use. Baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.",
"Description": "Baclofen is a gamma-aminobutyric acid (GABA-ergic) agonist available as 10 mg/5 mL solution for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Molecular formula is C 10H 12ClNO 2. Molecular Weight is 213.66. Baclofen, USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The baclofen oral solution inactive ingredients are: glycerin, methyl paraben, propyl paraben, sucralose, sodium carboxymethylcellulose, grape flavor, hydrochloride acid, sodium hydroxide, purified water."
},
{
"NDCCode": "73763-466-02",
"PackageDescription": "473 mL in 1 BOTTLE, DISPENSING (73763-466-02) ",
"NDC11Code": "73763-0466-02",
"ProductNDC": "73763-466",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sanitect Antibacterial Hand",
"NonProprietaryName": "Benzalkonium Chloride Soap",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200316",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Aquagenics Technologies",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200316",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing , helps eliminate bacteria on hands."
},
{
"NDCCode": "84522-466-02",
"PackageDescription": "15 mL in 1 BOTTLE (84522-466-02) ",
"NDC11Code": "84522-0466-02",
"ProductNDC": "84522-466",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Effectively Improves Skin Tone And Nourishes Skin",
"NonProprietaryName": "Effectively Improves Skin Tone And Nourishes Skin",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-466-02",
"PackageDescription": "15 mL in 1 BOTTLE (84756-466-02) ",
"NDC11Code": "84756-0466-02",
"ProductNDC": "84756-466",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hair Growth Essential Oil",
"NonProprietaryName": "Hair Growth Essential Oil",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241126",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241126",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "99207-466-02",
"PackageDescription": "10 BOTTLE in 1 CARTON (99207-466-02) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "99207-0466-02",
"ProductNDC": "99207-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solodyn",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100927",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050808",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100927",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "SOLODYN is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1).",
"Description": "Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. SOLODYN Tablets for oral administration contain minocycline hydrochloride USP equivalent to 55 mg, 65 mg, 80 mg, 105 mg, or 115 mg of minocycline. In addition, 55 mg, 65 mg, 80 mg, 105 mg, and 115 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2."
},
{
"NDCCode": "35573-309-02",
"PackageDescription": "57 g in 1 BOTTLE (35573-309-02)",
"NDC11Code": "35573-0309-02",
"ProductNDC": "35573-309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide And Sulfur",
"NonProprietaryName": "Sodium Sulfacetamide And Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160307",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Burel Pharmaceuticals, Inc",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 20",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "35573-330-02",
"PackageDescription": "57 g in 1 BOTTLE (35573-330-02)",
"NDC11Code": "35573-0330-02",
"ProductNDC": "35573-330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide And Sulfur",
"NonProprietaryName": "Sodium Sulfacetamide And Sulfur",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160314",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Burel Pharmaceuticals, Inc",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "98; 48",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "35573-413-02",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (35573-413-02) ",
"NDC11Code": "35573-0413-02",
"ProductNDC": "35573-413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209312",
"LabelerName": "Burel Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190930",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with \"G\" above the score line on one side and \"500\" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with \"G\" on one side and \"750\" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tablets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide."
},
{
"NDCCode": "35573-414-02",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (35573-414-02) ",
"NDC11Code": "35573-0414-02",
"ProductNDC": "35573-414",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209312",
"LabelerName": "Burel Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190930",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with \"G\" above the score line on one side and \"500\" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with \"G\" on one side and \"750\" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tablets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide."
},
{
"NDCCode": "35573-433-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (35573-433-02) ",
"NDC11Code": "35573-0433-02",
"ProductNDC": "35573-433",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoconazole",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075912",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200410",
"SamplePackage": "N",
"IndicationAndUsage": "Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.",
"Description": "Ketoconazole tablets USP is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxyl]phenyl] piperazine and has the following structural formula. Ketoconazole is a white to slightly beige, odorless powder, soluble in acids, with a molecular weight of 531.44g/mol. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "35573-436-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-436-02) ",
"NDC11Code": "35573-0436-02",
"ProductNDC": "35573-436",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076868",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "35573-437-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-437-02) ",
"NDC11Code": "35573-0437-02",
"ProductNDC": "35573-437",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076868",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "35573-438-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-438-02) ",
"NDC11Code": "35573-0438-02",
"ProductNDC": "35573-438",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076868",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "35573-439-02",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-439-02) ",
"NDC11Code": "35573-0439-02",
"ProductNDC": "35573-439",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076868",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "35573-440-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (35573-440-02) ",
"NDC11Code": "35573-0440-02",
"ProductNDC": "35573-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071130",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210531",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Each tablet for oral administration contains haloperidol USP, 2 mg. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, colloidal silicon dioxide and stearic acid."
},
{
"NDCCode": "35573-441-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (35573-441-02) ",
"NDC11Code": "35573-0441-02",
"ProductNDC": "35573-441",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210531",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071131",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210531",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N"
},
{
"NDCCode": "35573-442-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (35573-442-02) ",
"NDC11Code": "35573-0442-02",
"ProductNDC": "35573-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210531",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071132",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210531",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N"
},
{
"NDCCode": "35573-450-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (35573-450-02) ",
"NDC11Code": "35573-0450-02",
"ProductNDC": "35573-450",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210616",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220415",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine tablets, USP and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult PatientsKetorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with ketorolac tromethamine-IV or IM and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablet therapy is not to exceed 5 days.",
"Description": "Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-Benzoyl-2,3-dihydro-1H- pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural formula is. C15H13NO3 C4H11NO3. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.41. Each tablet for oral administration contains 10 mg ketorolac tromethamine, USP. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80, shellac glaze, isopropyl alcohol, black iron oxide, N-butyl alcohol, propylene glycol and ammonium hydroxide. FDA approved dissolution test specifications differ from USP."
}
]
}
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<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-466-02) </PackageDescription>
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<ProductNDC>35573-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20191216</StartMarketingDate>
<EndMarketingDate>20280229</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212037</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>3.75; 3.75; 3.75; 3.75</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>2025-12-19</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191216</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).</IndicationAndUsage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac.</Description>
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<PackageDescription>59 mL in 1 BOTTLE, DISPENSING (43333-466-02) </PackageDescription>
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<ProductNDC>43333-466</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<EndMarketingDate>20220330</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Tonic Bath & Body Products Shenzhen Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>65</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200407</StartMarketingDatePackage>
<EndMarketingDatePackage>20220330</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>50844-466-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50844-466-02) > 12 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50844-0466-02</NDC11Code>
<ProductNDC>50844-466</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinus Congestion And Pain</ProprietaryName>
<ProprietaryNameSuffix>Daytime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen And Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050726</StartMarketingDate>
<EndMarketingDate>20190810</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>L.N.K. International, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>51346-466-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (51346-466-02) > 13 g in 1 CONTAINER (51346-466-01)</PackageDescription>
<NDC11Code>51346-0466-02</NDC11Code>
<ProductNDC>51346-466</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Provence Air Skin Fit Oi L Control Bb Cushion 02 Natural Beige</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>1.24; 1.24; .91; .58</StrengthNumber>
<StrengthUnit>g/13g; g/13g; g/13g; g/13g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52125-466-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (52125-466-02)</PackageDescription>
<NDC11Code>52125-0466-02</NDC11Code>
<ProductNDC>52125-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018413</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>54575-466-02</NDCCode>
<PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (54575-466-02)</PackageDescription>
<NDC11Code>54575-0466-02</NDC11Code>
<ProductNDC>54575-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tomato</ProprietaryName>
<NonProprietaryName>Tomato</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>TOMATO</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
</NDC>
<NDC>
<NDCCode>61786-466-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (61786-466-02)</PackageDescription>
<NDC11Code>61786-0466-02</NDC11Code>
<ProductNDC>61786-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078154</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>63323-466-31</NDCCode>
<PackageDescription>5 VIAL, SINGLE-DOSE in 1 BOX (63323-466-31) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-466-02) </PackageDescription>
<NDC11Code>63323-0466-31</NDC11Code>
<ProductNDC>63323-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sensorcaine</ProprietaryName>
<ProprietaryNameSuffix>Mpf</ProprietaryNameSuffix>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20101119</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018304</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. (See DOSAGE AND ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.</IndicationAndUsage>
<Description>Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure:. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula:. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage.</Description>
</NDC>
<NDC>
<NDCCode>63545-466-02</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (63545-466-02) </PackageDescription>
<NDC11Code>63545-0466-02</NDC11Code>
<ProductNDC>63545-466</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carum Carvi</ProprietaryName>
<NonProprietaryName>Carum Carvi</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220511</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>CARAWAY SEED</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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<NDCCode>67209-466-02</NDCCode>
<PackageDescription>10 CARTON in 1 BOX (67209-466-02) > 10 BOTTLE in 1 CARTON > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>67209-0466-02</NDC11Code>
<ProductNDC>67209-466</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20100927</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>WellSpring Pharma Services Inc.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69085-466-02</NDCCode>
<PackageDescription>45 g in 1 TUBE (69085-466-02) </PackageDescription>
<NDC11Code>69085-0466-02</NDC11Code>
<ProductNDC>69085-466</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Omnicide Antimicrobial</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140702</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SteriWeb Medical, LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help treat, protect and prevent skin infection associated with: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69423-466-02</NDCCode>
<PackageDescription>3 CARTON in 1 CELLO PACK (69423-466-02) / 1 JAR in 1 CARTON / 48 g in 1 JAR</PackageDescription>
<NDC11Code>69423-0466-02</NDC11Code>
<ProductNDC>69423-466</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Olay Regenerist Whip Moisturizer Broad Spectrum Spf 25 Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 8; 4; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230130</StartMarketingDatePackage>
<EndMarketingDatePackage>20250301</EndMarketingDatePackage>
<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>72888-466-02</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (72888-466-02) </PackageDescription>
<NDC11Code>72888-0466-02</NDC11Code>
<ProductNDC>72888-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214445</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd.,</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen oral solution is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use. Baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.</IndicationAndUsage>
<Description>Baclofen is a gamma-aminobutyric acid (GABA-ergic) agonist available as 10 mg/5 mL solution for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Molecular formula is C 10H 12ClNO 2. Molecular Weight is 213.66. Baclofen, USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The baclofen oral solution inactive ingredients are: glycerin, methyl paraben, propyl paraben, sucralose, sodium carboxymethylcellulose, grape flavor, hydrochloride acid, sodium hydroxide, purified water.</Description>
</NDC>
<NDC>
<NDCCode>73763-466-02</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, DISPENSING (73763-466-02) </PackageDescription>
<NDC11Code>73763-0466-02</NDC11Code>
<ProductNDC>73763-466</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sanitect Antibacterial Hand</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride Soap</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200316</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Aquagenics Technologies</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing , helps eliminate bacteria on hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84522-466-02</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (84522-466-02) </PackageDescription>
<NDC11Code>84522-0466-02</NDC11Code>
<ProductNDC>84522-466</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Effectively Improves Skin Tone And Nourishes Skin</ProprietaryName>
<NonProprietaryName>Effectively Improves Skin Tone And Nourishes Skin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-466-02</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (84756-466-02) </PackageDescription>
<NDC11Code>84756-0466-02</NDC11Code>
<ProductNDC>84756-466</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hair Growth Essential Oil</ProprietaryName>
<NonProprietaryName>Hair Growth Essential Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241126</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>99207-466-02</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (99207-466-02) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>99207-0466-02</NDC11Code>
<ProductNDC>99207-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solodyn</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100927</StartMarketingDate>
<EndMarketingDate>20241031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050808</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100927</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOLODYN is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1).</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. SOLODYN Tablets for oral administration contain minocycline hydrochloride USP equivalent to 55 mg, 65 mg, 80 mg, 105 mg, or 115 mg of minocycline. In addition, 55 mg, 65 mg, 80 mg, 105 mg, and 115 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>35573-309-02</NDCCode>
<PackageDescription>57 g in 1 BOTTLE (35573-309-02)</PackageDescription>
<NDC11Code>35573-0309-02</NDC11Code>
<ProductNDC>35573-309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide And Sulfur</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide And Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160307</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Burel Pharmaceuticals, Inc</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>35573-330-02</NDCCode>
<PackageDescription>57 g in 1 BOTTLE (35573-330-02)</PackageDescription>
<NDC11Code>35573-0330-02</NDC11Code>
<ProductNDC>35573-330</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide And Sulfur</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide And Sulfur</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160314</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Burel Pharmaceuticals, Inc</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>98; 48</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>35573-413-02</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (35573-413-02) </PackageDescription>
<NDC11Code>35573-0413-02</NDC11Code>
<ProductNDC>35573-413</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209312</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with "G" above the score line on one side and "500" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and "750" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tablets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>35573-414-02</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (35573-414-02) </PackageDescription>
<NDC11Code>35573-0414-02</NDC11Code>
<ProductNDC>35573-414</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209312</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with "G" above the score line on one side and "500" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and "750" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tablets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>35573-433-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (35573-433-02) </PackageDescription>
<NDC11Code>35573-0433-02</NDC11Code>
<ProductNDC>35573-433</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoconazole</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075912</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.</IndicationAndUsage>
<Description>Ketoconazole tablets USP is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxyl]phenyl] piperazine and has the following structural formula. Ketoconazole is a white to slightly beige, odorless powder, soluble in acids, with a molecular weight of 531.44g/mol. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>35573-436-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (35573-436-02) </PackageDescription>
<NDC11Code>35573-0436-02</NDC11Code>
<ProductNDC>35573-436</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loxapine</ProprietaryName>
<NonProprietaryName>Loxapine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076868</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>35573-437-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (35573-437-02) </PackageDescription>
<NDC11Code>35573-0437-02</NDC11Code>
<ProductNDC>35573-437</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loxapine</ProprietaryName>
<NonProprietaryName>Loxapine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076868</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>35573-438-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (35573-438-02) </PackageDescription>
<NDC11Code>35573-0438-02</NDC11Code>
<ProductNDC>35573-438</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loxapine</ProprietaryName>
<NonProprietaryName>Loxapine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076868</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>35573-439-02</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (35573-439-02) </PackageDescription>
<NDC11Code>35573-0439-02</NDC11Code>
<ProductNDC>35573-439</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loxapine</ProprietaryName>
<NonProprietaryName>Loxapine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076868</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>35573-440-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (35573-440-02) </PackageDescription>
<NDC11Code>35573-0440-02</NDC11Code>
<ProductNDC>35573-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071130</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Each tablet for oral administration contains haloperidol USP, 2 mg. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, colloidal silicon dioxide and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>35573-441-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (35573-441-02) </PackageDescription>
<NDC11Code>35573-0441-02</NDC11Code>
<ProductNDC>35573-441</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210531</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071131</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210531</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>35573-442-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (35573-442-02) </PackageDescription>
<NDC11Code>35573-0442-02</NDC11Code>
<ProductNDC>35573-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210531</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071132</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210531</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>35573-450-02</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (35573-450-02) </PackageDescription>
<NDC11Code>35573-0450-02</NDC11Code>
<ProductNDC>35573-450</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210616</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine tablets, USP and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult PatientsKetorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with ketorolac tromethamine-IV or IM and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablet therapy is not to exceed 5 days.</IndicationAndUsage>
<Description>Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-Benzoyl-2,3-dihydro-1H- pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural formula is. C15H13NO3 C4H11NO3. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.41. Each tablet for oral administration contains 10 mg ketorolac tromethamine, USP. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80, shellac glaze, isopropyl alcohol, black iron oxide, N-butyl alcohol, propylene glycol and ammonium hydroxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
</NDCList>