RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "21922-052-50",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (21922-052-50)  / 45 g in 1 BOTTLE, PUMP",
      "NDC11Code": "21922-0052-50",
      "ProductNDC": "21922-052",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%",
      "NonProprietaryName": "Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230814",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206164",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
      "StrengthNumber": "1; 25",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2026-06-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230814",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
      "Description": "Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C28H28O3     Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C14H10O4        Molecular weight: 242.23. Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% contains the following inactive ingredients: carbopol 980, d-limonene, docusate sodium solution, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sodium hydroxide and sorbitan monooleate."
    },
    {
      "NDCCode": "21922-015-40",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (21922-015-40)  / 50 g in 1 BOTTLE, PUMP",
      "NDC11Code": "21922-0015-40",
      "ProductNDC": "21922-015",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Estradiol",
      "NonProprietaryName": "Estradiol",
      "DosageFormName": "GEL",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20260513",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218214",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "ESTRADIOL",
      "StrengthNumber": ".75",
      "StrengthUnit": "mg/1.25g",
      "Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260513",
      "SamplePackage": "N",
      "Description": "Estradiol gel contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless gel, which is odorless when dry. One pump depression of estradiol gel delivers 1.25 g of gel containing 0.75 mg estradiol. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol (46.12%), trolamine and carbopol 974 P polymer) are pharmacologically inactive."
    },
    {
      "NDCCode": "21922-038-14",
      "PackageDescription": "1 TUBE in 1 CARTON (21922-038-14)  / 50 g in 1 TUBE",
      "NDC11Code": "21922-0038-14",
      "ProductNDC": "21922-038",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azelaic Acid Gel",
      "NonProprietaryName": "Azelaic Acid",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20231130",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208724",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "AZELAIC ACID",
      "StrengthNumber": ".15",
      "StrengthUnit": "g/g",
      "Pharm_Classes": "Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231130",
      "SamplePackage": "N",
      "IndicationAndUsage": "Azelaic Acid Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.Limitations of Use. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.",
      "Description": "Azelaic Acid Gel, 15%, is an aqueous gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The molecular formula for azelaic acid is C9 H16 O4. It has the following structure. Azelaic acid has a molecular weight of 188.22. It is a white, odorless crystalline solid. It is poorly soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol.Azelaic Acid Gel, 15% is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm azelaic acid (15% w/w) in an aqueous gel base containing benzoic acid (as a preservative), caprylic/capric triglycerides, carbopol 980, edetate disodium, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH."
    },
    {
      "NDCCode": "21922-042-40",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (21922-042-40)  / 50 g in 1 BOTTLE, PUMP",
      "NDC11Code": "21922-0042-40",
      "ProductNDC": "21922-042",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tretinoin",
      "NonProprietaryName": "Tretinoin",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260416",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215609",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "TRETINOIN",
      "StrengthNumber": ".6",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260416",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tretinoin gel (microsphere) is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
      "Description": "Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1- cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C20H28O2 and the following chemical structure. Tretinoin gel (microsphere) is for topical use. Each gram of tretinoin gel (microsphere): 1 0.06%, contains 0.6 mg of tretinoin, 2 0.08%, contains 0.8 mg of tretinoin."
    },
    {
      "NDCCode": "21922-043-40",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (21922-043-40)  / 50 g in 1 BOTTLE, PUMP",
      "NDC11Code": "21922-0043-40",
      "ProductNDC": "21922-043",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tretinoin",
      "NonProprietaryName": "Tretinoin",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230824",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215609",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "TRETINOIN",
      "StrengthNumber": ".8",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230824",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tretinoin gel (microsphere) is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
      "Description": "Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1- cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C20H28O2 and the following chemical structure. Tretinoin gel (microsphere) is for topical use. Each gram of tretinoin gel (microsphere): 1 0.06%, contains 0.6 mg of tretinoin, 2 0.08%, contains 0.8 mg of tretinoin."
    },
    {
      "NDCCode": "21922-044-14",
      "PackageDescription": "1 TUBE in 1 CARTON (21922-044-14)  / 50 g in 1 TUBE",
      "NDC11Code": "21922-0044-14",
      "ProductNDC": "21922-044",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium Topical Gel, 1%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200811",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210986",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210201",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas)foot, ankle, knee (lower body areas). this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use."
    },
    {
      "NDCCode": "21922-051-50",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (21922-051-50)  / 45 g in 1 BOTTLE, PUMP",
      "NDC11Code": "21922-0051-50",
      "ProductNDC": "21922-051",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Adapalene Gel Usp, 0.3%",
      "NonProprietaryName": "Adapalene Gel Usp, 0.3%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230807",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200298",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "ADAPALENE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2025-09-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230810",
      "SamplePackage": "N",
      "IndicationAndUsage": "ADAPALENE Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
      "Description": "Adapalene Gel USP, 0.3% contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 980, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula."
    },
    {
      "NDCCode": "21922-061-27",
      "PackageDescription": "1 BOTTLE in 1 CARTON (21922-061-27)  / 50 mL in 1 BOTTLE",
      "NDC11Code": "21922-0061-27",
      "ProductNDC": "21922-061",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clobetasol Propionate",
      "NonProprietaryName": "Clobetasol Propionate",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240610",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076977",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "CLOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240610",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clobetasol Propionate Topical Solution, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.",
      "Description": "Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbopol 974P, isopropyl alcohol (39.3%), purified water and sodium hydroxide."
    },
    {
      "NDCCode": "21922-074-40",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (21922-074-40)  / 50 g in 1 BOTTLE, PUMP",
      "NDC11Code": "21922-0074-40",
      "ProductNDC": "21922-074",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin Phosphate And Benzoyl Peroxide",
      "NonProprietaryName": "Clindamycin Phosphate And Benzoyl Peroxide",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207194",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE",
      "StrengthNumber": "10; 25",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clindamycin phosphate and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.",
      "Description": "Clindamycin phosphate and benzoyl peroxide gel, 1.2% / 2.5% is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.The chemical name for clindamycin phosphate is Methyl 7 chloro-6,7,8-trideoxy- 6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo α-D-galacto octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below:Clindamycin phosphate. Molecular Formula: C18H34CIN2O8PS                 Molecular Weight: 504.97. Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below:Benzoyl peroxide. Molecular Formula: C14H10O4                     Molecular Weight: 242.23. Clindamycin phosphate and benzoyl peroxide gel contains the following inactive ingredients: carbopol 980, poloxamer 182, polysorbate 80, propylene glycol, purified water and sodium hydroxide. Each gram of clindamycin phosphate and benzoyl peroxide gel contains 1.2% of clindamycin phosphate which is equivalent to 1% clindamycin."
    },
    {
      "NDCCode": "21922-107-61",
      "PackageDescription": "50 g in 1 JAR (21922-107-61) ",
      "NDC11Code": "21922-0107-61",
      "ProductNDC": "21922-107",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidocaine",
      "NonProprietaryName": "Lidicaine",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260620",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205318",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "LIDOCAINE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260620",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lidocaine ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.",
      "Description": "Lidocaine ointment USP, 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGE for specific uses. Lidocaine ointment USP, 5% contains lidocaine, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula. Composition of lidocaine ointment USP, 5%: acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, (lidocaine) 5% in a water miscible ointment vehicle containing polyethylene glycol 300 and polyethylene glycol 1450."
    },
    {
      "NDCCode": "21922-108-14",
      "PackageDescription": "1 TUBE in 1 CARTON (21922-108-14)  / 50 g in 1 TUBE",
      "NDC11Code": "21922-0108-14",
      "ProductNDC": "21922-108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Halobetasol Propionate",
      "NonProprietaryName": "Halobetasol Propionate",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209978",
      "LabelerName": "Encube Ethicals, Inc.",
      "SubstanceName": "HALOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Halobetasol propionate ointment, 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
      "Description": "Halobetasol propionate ointment, 0.05% contains Halobetasol propionate, a synthetic corticosteroid for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti- inflammatory and antipruritic agent. Chemically halobetasol propionate is 21-chloro-6a, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna- 1, 4-diene-3-20-dione, 17-propionate, C25H31CIF205. It has the following structural formula. Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in water. Each gram of halobetasol propionate ointment contains 0.5mg/g of halobetasol propionate in a base of aluminum stearate, beeswax, pentaerythritol cocoate, petrolatum, propylene glycol, sorbitan sesquioleate, and stearyl citrate."
    },
    {
      "NDCCode": "11559-052-01",
      "PackageDescription": "1 JAR in 1 CARTON (11559-052-01)  / 50 mL in 1 JAR",
      "NDC11Code": "11559-0052-01",
      "ProductNDC": "11559-052",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Resilience Multi-effect Tri-peptide Face And Neck Creme Broad Spectrum Spf 15",
      "NonProprietaryName": "Avobenzone, Octisalate, And Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "ESTEE LAUDER INC",
      "SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "30; 45; 27",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181101",
      "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": "20151-052-02",
      "PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (20151-052-02)  > 50 mL in 1 BOTTLE, DISPENSING (20151-052-01)",
      "NDC11Code": "20151-0052-02",
      "ProductNDC": "20151-052",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Purifying Oxygenating Serum",
      "NonProprietaryName": "Glycerin, Dimethicone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150630",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "Casmara Cosmetics, SA",
      "SubstanceName": "DIMETHICONE; GLYCERIN",
      "StrengthNumber": ".75; 12",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-07-24"
    },
    {
      "NDCCode": "29033-052-50",
      "PackageDescription": "50 CAPSULE in 1 BOTTLE (29033-052-50) ",
      "NDC11Code": "29033-0052-50",
      "ProductNDC": "29033-052",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline Hyclate",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201221",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209393",
      "LabelerName": "Nostrum Laboratories, Inc.",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-04-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20201221",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "42851-158-60",
      "PackageDescription": "1 KIT in 1 CARTON (42851-158-60)  *  30 mL in 1 TUBE *  30 mL in 1 BOTTLE, PUMP *  60 g in 1 TUBE (42851-052-60)  *  50 mL in 1 TUBE, WITH APPLICATOR",
      "NDC11Code": "42851-0158-60",
      "ProductNDC": "42851-158",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zo Medical Zo Non-hydroquinone Hyperpigmentation System For Skin Brightening",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20151101",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "ZO Skin Health, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "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": "42961-052-03",
      "PackageDescription": "50 CARTON in 1 CARTON (42961-052-03)  > 125 PACKET in 1 CARTON (42961-052-02)  > 2 TABLET in 1 PACKET (42961-052-01) ",
      "NDC11Code": "42961-0052-03",
      "ProductNDC": "42961-052",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dilotab Ii",
      "NonProprietaryName": "Acetaminophen Phenylephrine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210107",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Cintas Corporation",
      "SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210107",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49967-052-03",
      "PackageDescription": "50 mL in 1 BOTTLE (49967-052-03) ",
      "NDC11Code": "49967-0052-03",
      "ProductNDC": "49967-052",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Matrix Biolage Scalpsync Antidandruff",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140501",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "L'Oreal USA Products Inc",
      "SubstanceName": "PYRITHIONE ZINC",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2024-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240201",
      "SamplePackage": "N",
      "IndicationAndUsage": "fights scalp scaling, itching and flaking due to dandruff."
    },
    {
      "NDCCode": "50268-052-15",
      "PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-052-15)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-052-11) ",
      "NDC11Code": "50268-0052-15",
      "ProductNDC": "50268-052",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arthritis Pain Reliever",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160307",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076200",
      "LabelerName": "AvPAK",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "650",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20160307",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to:. minor pain of arthritis. muscular aches. backache. premenstrual and menstrual cramps. the common cold. headache. toothache. temporarily reduces fever."
    },
    {
      "NDCCode": "51060-052-01",
      "PackageDescription": "1 TUBE in 1 CARTON (51060-052-01)  > 50 mL in 1 TUBE",
      "NDC11Code": "51060-0052-01",
      "ProductNDC": "51060-052",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Amazonian Clay 12-hour Full Coverage Foundation Broad Spectrum Spf 15 Sunscreen",
      "ProprietaryNameSuffix": "Light Beige",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130701",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Tarte, Inc",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "60; 30",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20130701",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51144-052-81",
      "PackageDescription": "4 TRAY in 1 BOX (51144-052-81)  > 81 VIAL in 1 TRAY > 50 mg in 1 VIAL",
      "NDC11Code": "51144-0052-81",
      "ProductNDC": "51144-052",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Brentuximab Vedotin",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "StartMarketingDate": "20110825",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Seattle Genetics, Inc.",
      "SubstanceName": "BRENTUXIMAB VEDOTIN",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "51621-052-02",
      "PackageDescription": "1 TUBE in 1 CARTON (51621-052-02)  > 50 mg in 1 TUBE (51621-052-01)",
      "NDC11Code": "51621-0052-02",
      "ProductNDC": "51621-052",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr.g Medi Uv Ultra Sun Spf 50 Plus Pa Plus Plus Plus",
      "NonProprietaryName": "Zinc Oxide And Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20141115",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "GOWOONSESANG COSMETICS CO., LTD.",
      "SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
      "StrengthNumber": "5; 4",
      "StrengthUnit": "mg/100mg; mg/100mg",
      "Status": "Deprecated",
      "LastUpdate": "2018-03-23",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "62331-052-31",
      "PackageDescription": "50 kg in 1 DRUM (62331-052-31)",
      "NDC11Code": "62331-0052-31",
      "ProductNDC": "62331-052",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Fexofenadine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20110622",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Divis Laboratories Limited",
      "SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "65162-052-50",
      "PackageDescription": "500 TABLET in 1 BOTTLE (65162-052-50) ",
      "NDC11Code": "65162-0052-50",
      "ProductNDC": "65162-052",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Citalopram",
      "NonProprietaryName": "Citalopram",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100406",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077289",
      "LabelerName": "Amneal Pharmaceuticals LLC",
      "SubstanceName": "CITALOPRAM HYDROBROMIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100406",
      "SamplePackage": "N",
      "IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
      "Description": "Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide, USP is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3 dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide, USP is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated oval tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.5 mg, 25 mg, and 50 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copolyvidone, corn starch, glycerin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Iron oxides are used as coloring agents in the light orange (10 mg) and pink (20 mg) tablets."
    },
    {
      "NDCCode": "66343-052-50",
      "PackageDescription": "50 mL in 1 BOTTLE (66343-052-50) ",
      "NDC11Code": "66343-0052-50",
      "ProductNDC": "66343-052",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Emvita 3",
      "NonProprietaryName": "Apis Mellifica, Conium, Oophorinum, Bovista, Hepar Sulph Calc, Orchitinum",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190603",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "RUBIMED AG",
      "SubstanceName": "APIS MELLIFERA; CONIUM MACULATUM FLOWERING TOP; SUS SCROFA OVARY; LYCOPERDON UTRIFORME FRUITING BODY; CALCIUM SULFIDE; SUS SCROFA TESTICLE",
      "StrengthNumber": "800; 18; 21; 21; 16; 21",
      "StrengthUnit": "[hp_C]/50mL; [hp_M]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_M]/50mL; [hp_X]/50mL",
      "Pharm_Classes": "Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Bee Venoms [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190603",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "67544-052-50",
      "PackageDescription": "50 TABLET in 1 BOTTLE, PLASTIC (67544-052-50)",
      "NDC11Code": "67544-0052-50",
      "ProductNDC": "67544-052",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Coumadin",
      "NonProprietaryName": "Warfarin Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA009218",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, Inc.",
      "SubstanceName": "WARFARIN SODIUM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-03-29",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "69844-052-01",
      "PackageDescription": "50 TABLET in 1 BOTTLE (69844-052-01) ",
      "NDC11Code": "69844-0052-01",
      "ProductNDC": "69844-052",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Furosemide",
      "NonProprietaryName": "Furosemide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221017",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216629",
      "LabelerName": "Graviti Pharmaceuticals Private Limited",
      "SubstanceName": "FUROSEMIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20221017",
      "SamplePackage": "N",
      "IndicationAndUsage": "Edema. Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide Tablets are particularly useful when an agent with greater diuretic potential is desired. Hypertension. Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.",
      "Description": "Furosemide Tablets, USP are a diuretic which is an anthranilic acid derivative. Furosemide tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: lactose monohydrate, corn starch, pregelatinized starch, talc, colloidal silicon dioxide, magnesium stearate. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide tablets are available as white tablets for oral administration in dosage strengths of 20 mg, 40 mg and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Meets USP dissolution test 1."
    },
    {
      "NDCCode": "70529-052-01",
      "PackageDescription": "1 KIT in 1 PACKAGE (70529-052-01)  *  1 mL in 1 VIAL *  1 mL in 1 PACKET *  50 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "70529-0052-01",
      "ProductNDC": "70529-052",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Omnitrenidol",
      "NonProprietaryName": "Lidocaine Hydrochloride, Triamcinolone Acetonide",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20181101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088299",
      "LabelerName": "IT3 Medical LLC",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20181101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70600-052-01",
      "PackageDescription": "50 kg in 1 DRUM (70600-052-01) ",
      "NDC11Code": "70600-0052-01",
      "ProductNDC": "70600-052",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Manganese Sulfate Monohydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20240329",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Maithri Drugs Private Limited",
      "SubstanceName": "MANGANESE SULFATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-04-11",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "29-MAR-24"
    },
    {
      "NDCCode": "70954-052-10",
      "PackageDescription": "50 TABLET in 1 BOTTLE (70954-052-10) ",
      "NDC11Code": "70954-0052-10",
      "ProductNDC": "70954-052",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocortisone",
      "NonProprietaryName": "Hydrocortisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250505",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217881",
      "LabelerName": "ANI Pharmaceuticals, Inc.",
      "SubstanceName": "HYDROCORTISONE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250505",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrocortisone tablets are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Non suppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitis. Serum sickness. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic conjunctivitis. Keratitis. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Iritis and iridocyclitis. Chorioretinitis. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. 7. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
      "Description": "Hydrocortisone Tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone, USP is white to practically white, odorless, crystalline powder with a melting point of about 215°C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone Tablets, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of Hydrocortisone, USP. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. FDA approved dissolution test and specifications differs from the USP."
    },
    {
      "NDCCode": "71447-052-01",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (71447-052-01)  > 50 g in 1 BOTTLE, PLASTIC (71447-052-00) ",
      "NDC11Code": "71447-0052-01",
      "ProductNDC": "71447-052",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lani And Kai Mineral Sunscreen",
      "ProprietaryNameSuffix": "Spf30",
      "NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "LABORATOIRES DRUIDE INC",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "2; 18.4",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210301",
      "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."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"21922-052-50","ProprietaryName":"Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%","NonProprietaryName":"Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%"},{"NDCCode":"21922-015-40","ProprietaryName":"Estradiol","NonProprietaryName":"Estradiol"},{"NDCCode":"21922-038-14","ProprietaryName":"Azelaic Acid Gel","NonProprietaryName":"Azelaic Acid"},{"NDCCode":"21922-042-40","ProprietaryName":"Tretinoin","NonProprietaryName":"Tretinoin"},{"NDCCode":"21922-043-40","ProprietaryName":"Tretinoin","NonProprietaryName":"Tretinoin"},{"NDCCode":"21922-044-14","ProprietaryName":"Diclofenac Sodium","NonProprietaryName":"Diclofenac Sodium Topical Gel, 1%"},{"NDCCode":"21922-051-50","ProprietaryName":"Adapalene Gel Usp, 0.3%","NonProprietaryName":"Adapalene Gel Usp, 0.3%"},{"NDCCode":"21922-061-27","ProprietaryName":"Clobetasol Propionate","NonProprietaryName":"Clobetasol Propionate"},{"NDCCode":"21922-074-40","ProprietaryName":"Clindamycin Phosphate And Benzoyl Peroxide","NonProprietaryName":"Clindamycin Phosphate And Benzoyl Peroxide"},{"NDCCode":"21922-107-61","ProprietaryName":"Lidocaine","NonProprietaryName":"Lidicaine"},{"NDCCode":"21922-108-14","ProprietaryName":"Halobetasol Propionate","NonProprietaryName":"Halobetasol Propionate"},{"NDCCode":"11559-052-01","ProprietaryName":"Resilience Multi-effect Tri-peptide Face And Neck Creme Broad Spectrum Spf 15","NonProprietaryName":"Avobenzone, Octisalate, And Octocrylene"},{"NDCCode":"20151-052-02","ProprietaryName":"Purifying Oxygenating Serum","NonProprietaryName":"Glycerin, Dimethicone"},{"NDCCode":"29033-052-50","ProprietaryName":"Doxycycline Hyclate","NonProprietaryName":"Doxycycline Hyclate"},{"NDCCode":"42851-158-60","ProprietaryName":"Zo Medical Zo Non-hydroquinone Hyperpigmentation System For Skin Brightening","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"42961-052-03","ProprietaryName":"Dilotab Ii","NonProprietaryName":"Acetaminophen Phenylephrine"},{"NDCCode":"49967-052-03","ProprietaryName":"Matrix Biolage Scalpsync Antidandruff","NonProprietaryName":"Pyrithione Zinc"},{"NDCCode":"50268-052-15","ProprietaryName":"Arthritis Pain Reliever","NonProprietaryName":"Acetaminophen"},{"NDCCode":"51060-052-01","ProprietaryName":"Amazonian Clay 12-hour Full Coverage Foundation Broad Spectrum Spf 15 Sunscreen","NonProprietaryName":"Titanium Dioxide And Zinc Oxide"},{"NDCCode":"51144-052-81","NonProprietaryName":"Brentuximab Vedotin"},{"NDCCode":"51621-052-02","ProprietaryName":"Dr.g Medi Uv Ultra Sun Spf 50 Plus Pa Plus Plus Plus","NonProprietaryName":"Zinc Oxide And Titanium Dioxide"},{"NDCCode":"62331-052-31","NonProprietaryName":"Fexofenadine Hydrochloride"},{"NDCCode":"65162-052-50","ProprietaryName":"Citalopram","NonProprietaryName":"Citalopram"},{"NDCCode":"66343-052-50","ProprietaryName":"Emvita 3","NonProprietaryName":"Apis Mellifica, Conium, Oophorinum, Bovista, Hepar Sulph Calc, Orchitinum"},{"NDCCode":"67544-052-50","ProprietaryName":"Coumadin","NonProprietaryName":"Warfarin Sodium"},{"NDCCode":"69844-052-01","ProprietaryName":"Furosemide","NonProprietaryName":"Furosemide"},{"NDCCode":"70529-052-01","ProprietaryName":"Omnitrenidol","NonProprietaryName":"Lidocaine Hydrochloride, Triamcinolone Acetonide"},{"NDCCode":"70600-052-01","NonProprietaryName":"Manganese Sulfate Monohydrate"},{"NDCCode":"70954-052-10","ProprietaryName":"Hydrocortisone","NonProprietaryName":"Hydrocortisone"},{"NDCCode":"71447-052-01","ProprietaryName":"Lani And Kai Mineral Sunscreen","NonProprietaryName":"Titanium Dioxide, Zinc Oxide"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>21922-052-50</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (21922-052-50)  / 45 g in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>21922-0052-50</NDC11Code>
    <ProductNDC>21922-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%</ProprietaryName>
    <NonProprietaryName>Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230814</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206164</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
    <StrengthNumber>1; 25</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230814</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
    <Description>Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C28H28O3     Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C14H10O4        Molecular weight: 242.23. Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% contains the following inactive ingredients: carbopol 980, d-limonene, docusate sodium solution, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sodium hydroxide and sorbitan monooleate.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-015-40</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (21922-015-40)  / 50 g in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>21922-0015-40</NDC11Code>
    <ProductNDC>21922-015</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20260513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218214</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>.75</StrengthNumber>
    <StrengthUnit>mg/1.25g</StrengthUnit>
    <Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Estradiol gel contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless gel, which is odorless when dry. One pump depression of estradiol gel delivers 1.25 g of gel containing 0.75 mg estradiol. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol (46.12%), trolamine and carbopol 974 P polymer) are pharmacologically inactive.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-038-14</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21922-038-14)  / 50 g in 1 TUBE</PackageDescription>
    <NDC11Code>21922-0038-14</NDC11Code>
    <ProductNDC>21922-038</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azelaic Acid Gel</ProprietaryName>
    <NonProprietaryName>Azelaic Acid</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20231130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208724</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>AZELAIC ACID</SubstanceName>
    <StrengthNumber>.15</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Azelaic Acid Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.Limitations of Use. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.</IndicationAndUsage>
    <Description>Azelaic Acid Gel, 15%, is an aqueous gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The molecular formula for azelaic acid is C9 H16 O4. It has the following structure. Azelaic acid has a molecular weight of 188.22. It is a white, odorless crystalline solid. It is poorly soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol.Azelaic Acid Gel, 15% is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm azelaic acid (15% w/w) in an aqueous gel base containing benzoic acid (as a preservative), caprylic/capric triglycerides, carbopol 980, edetate disodium, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-042-40</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (21922-042-40)  / 50 g in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>21922-0042-40</NDC11Code>
    <ProductNDC>21922-042</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tretinoin</ProprietaryName>
    <NonProprietaryName>Tretinoin</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260416</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215609</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>TRETINOIN</SubstanceName>
    <StrengthNumber>.6</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260416</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tretinoin gel (microsphere) is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
    <Description>Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1- cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C20H28O2 and the following chemical structure. Tretinoin gel (microsphere) is for topical use. Each gram of tretinoin gel (microsphere): 1 0.06%, contains 0.6 mg of tretinoin, 2 0.08%, contains 0.8 mg of tretinoin.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-043-40</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (21922-043-40)  / 50 g in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>21922-0043-40</NDC11Code>
    <ProductNDC>21922-043</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tretinoin</ProprietaryName>
    <NonProprietaryName>Tretinoin</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230824</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215609</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>TRETINOIN</SubstanceName>
    <StrengthNumber>.8</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230824</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tretinoin gel (microsphere) is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
    <Description>Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1- cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C20H28O2 and the following chemical structure. Tretinoin gel (microsphere) is for topical use. Each gram of tretinoin gel (microsphere): 1 0.06%, contains 0.6 mg of tretinoin, 2 0.08%, contains 0.8 mg of tretinoin.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-044-14</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21922-044-14)  / 50 g in 1 TUBE</PackageDescription>
    <NDC11Code>21922-0044-14</NDC11Code>
    <ProductNDC>21922-044</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium Topical Gel, 1%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200811</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210986</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas)foot, ankle, knee (lower body areas). this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21922-051-50</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (21922-051-50)  / 45 g in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>21922-0051-50</NDC11Code>
    <ProductNDC>21922-051</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Adapalene Gel Usp, 0.3%</ProprietaryName>
    <NonProprietaryName>Adapalene Gel Usp, 0.3%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230807</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200298</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>ADAPALENE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230810</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ADAPALENE Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.</IndicationAndUsage>
    <Description>Adapalene Gel USP, 0.3% contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 980, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-061-27</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21922-061-27)  / 50 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>21922-0061-27</NDC11Code>
    <ProductNDC>21922-061</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240610</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076977</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobetasol Propionate Topical Solution, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.</IndicationAndUsage>
    <Description>Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbopol 974P, isopropyl alcohol (39.3%), purified water and sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-074-40</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (21922-074-40)  / 50 g in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>21922-0074-40</NDC11Code>
    <ProductNDC>21922-074</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin Phosphate And Benzoyl Peroxide</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate And Benzoyl Peroxide</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207194</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE</SubstanceName>
    <StrengthNumber>10; 25</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin phosphate and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.</IndicationAndUsage>
    <Description>Clindamycin phosphate and benzoyl peroxide gel, 1.2% / 2.5% is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.The chemical name for clindamycin phosphate is Methyl 7 chloro-6,7,8-trideoxy- 6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo α-D-galacto octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below:Clindamycin phosphate. Molecular Formula: C18H34CIN2O8PS                 Molecular Weight: 504.97. Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below:Benzoyl peroxide. Molecular Formula: C14H10O4                     Molecular Weight: 242.23. Clindamycin phosphate and benzoyl peroxide gel contains the following inactive ingredients: carbopol 980, poloxamer 182, polysorbate 80, propylene glycol, purified water and sodium hydroxide. Each gram of clindamycin phosphate and benzoyl peroxide gel contains 1.2% of clindamycin phosphate which is equivalent to 1% clindamycin.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-107-61</NDCCode>
    <PackageDescription>50 g in 1 JAR (21922-107-61) </PackageDescription>
    <NDC11Code>21922-0107-61</NDC11Code>
    <ProductNDC>21922-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine</ProprietaryName>
    <NonProprietaryName>Lidicaine</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260620</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205318</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.</IndicationAndUsage>
    <Description>Lidocaine ointment USP, 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGE for specific uses. Lidocaine ointment USP, 5% contains lidocaine, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula. Composition of lidocaine ointment USP, 5%: acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, (lidocaine) 5% in a water miscible ointment vehicle containing polyethylene glycol 300 and polyethylene glycol 1450.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-108-14</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21922-108-14)  / 50 g in 1 TUBE</PackageDescription>
    <NDC11Code>21922-0108-14</NDC11Code>
    <ProductNDC>21922-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Halobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Halobetasol Propionate</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209978</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>HALOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Halobetasol propionate ointment, 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
    <Description>Halobetasol propionate ointment, 0.05% contains Halobetasol propionate, a synthetic corticosteroid for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti- inflammatory and antipruritic agent. Chemically halobetasol propionate is 21-chloro-6a, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna- 1, 4-diene-3-20-dione, 17-propionate, C25H31CIF205. It has the following structural formula. Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in water. Each gram of halobetasol propionate ointment contains 0.5mg/g of halobetasol propionate in a base of aluminum stearate, beeswax, pentaerythritol cocoate, petrolatum, propylene glycol, sorbitan sesquioleate, and stearyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>11559-052-01</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (11559-052-01)  / 50 mL in 1 JAR</PackageDescription>
    <NDC11Code>11559-0052-01</NDC11Code>
    <ProductNDC>11559-052</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Resilience Multi-effect Tri-peptide Face And Neck Creme Broad Spectrum Spf 15</ProprietaryName>
    <NonProprietaryName>Avobenzone, Octisalate, And Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20181101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>ESTEE LAUDER INC</LabelerName>
    <SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>30; 45; 27</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>20151-052-02</NDCCode>
    <PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (20151-052-02)  &gt; 50 mL in 1 BOTTLE, DISPENSING (20151-052-01)</PackageDescription>
    <NDC11Code>20151-0052-02</NDC11Code>
    <ProductNDC>20151-052</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Purifying Oxygenating Serum</ProprietaryName>
    <NonProprietaryName>Glycerin, Dimethicone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>Casmara Cosmetics, SA</LabelerName>
    <SubstanceName>DIMETHICONE; GLYCERIN</SubstanceName>
    <StrengthNumber>.75; 12</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-24</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>29033-052-50</NDCCode>
    <PackageDescription>50 CAPSULE in 1 BOTTLE (29033-052-50) </PackageDescription>
    <NDC11Code>29033-0052-50</NDC11Code>
    <ProductNDC>29033-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209393</ApplicationNumber>
    <LabelerName>Nostrum Laboratories, Inc.</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-04-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42851-158-60</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (42851-158-60)  *  30 mL in 1 TUBE *  30 mL in 1 BOTTLE, PUMP *  60 g in 1 TUBE (42851-052-60)  *  50 mL in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>42851-0158-60</NDC11Code>
    <ProductNDC>42851-158</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zo Medical Zo Non-hydroquinone Hyperpigmentation System For Skin Brightening</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20151101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>ZO Skin Health, Inc.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <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>42961-052-03</NDCCode>
    <PackageDescription>50 CARTON in 1 CARTON (42961-052-03)  &gt; 125 PACKET in 1 CARTON (42961-052-02)  &gt; 2 TABLET in 1 PACKET (42961-052-01) </PackageDescription>
    <NDC11Code>42961-0052-03</NDC11Code>
    <ProductNDC>42961-052</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dilotab Ii</ProprietaryName>
    <NonProprietaryName>Acetaminophen Phenylephrine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210107</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Cintas Corporation</LabelerName>
    <SubstanceName>ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210107</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49967-052-03</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE (49967-052-03) </PackageDescription>
    <NDC11Code>49967-0052-03</NDC11Code>
    <ProductNDC>49967-052</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Matrix Biolage Scalpsync Antidandruff</ProprietaryName>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140501</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>L'Oreal USA Products Inc</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-07-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>fights scalp scaling, itching and flaking due to dandruff.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50268-052-15</NDCCode>
    <PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-052-15)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-052-11) </PackageDescription>
    <NDC11Code>50268-0052-15</NDC11Code>
    <ProductNDC>50268-052</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Arthritis Pain Reliever</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160307</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076200</ApplicationNumber>
    <LabelerName>AvPAK</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>650</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to:. minor pain of arthritis. muscular aches. backache. premenstrual and menstrual cramps. the common cold. headache. toothache. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51060-052-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (51060-052-01)  &gt; 50 mL in 1 TUBE</PackageDescription>
    <NDC11Code>51060-0052-01</NDC11Code>
    <ProductNDC>51060-052</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Amazonian Clay 12-hour Full Coverage Foundation Broad Spectrum Spf 15 Sunscreen</ProprietaryName>
    <ProprietaryNameSuffix>Light Beige</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Tarte, Inc</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>60; 30</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51144-052-81</NDCCode>
    <PackageDescription>4 TRAY in 1 BOX (51144-052-81)  &gt; 81 VIAL in 1 TRAY &gt; 50 mg in 1 VIAL</PackageDescription>
    <NDC11Code>51144-0052-81</NDC11Code>
    <ProductNDC>51144-052</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Brentuximab Vedotin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <StartMarketingDate>20110825</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Seattle Genetics, Inc.</LabelerName>
    <SubstanceName>BRENTUXIMAB VEDOTIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51621-052-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (51621-052-02)  &gt; 50 mg in 1 TUBE (51621-052-01)</PackageDescription>
    <NDC11Code>51621-0052-02</NDC11Code>
    <ProductNDC>51621-052</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr.g Medi Uv Ultra Sun Spf 50 Plus Pa Plus Plus Plus</ProprietaryName>
    <NonProprietaryName>Zinc Oxide And Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20141115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>GOWOONSESANG COSMETICS CO., LTD.</LabelerName>
    <SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>5; 4</StrengthNumber>
    <StrengthUnit>mg/100mg; mg/100mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-23</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>62331-052-31</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (62331-052-31)</PackageDescription>
    <NDC11Code>62331-0052-31</NDC11Code>
    <ProductNDC>62331-052</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20110622</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Divis Laboratories Limited</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>65162-052-50</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (65162-052-50) </PackageDescription>
    <NDC11Code>65162-0052-50</NDC11Code>
    <ProductNDC>65162-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram</ProprietaryName>
    <NonProprietaryName>Citalopram</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100406</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077289</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100406</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide, USP is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3 dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide, USP is sparingly soluble in water and soluble in ethanol. Citalopram tablets, USP are for oral administration and are available as film-coated oval tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.5 mg, 25 mg, and 50 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copolyvidone, corn starch, glycerin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Iron oxides are used as coloring agents in the light orange (10 mg) and pink (20 mg) tablets.</Description>
  </NDC>
  <NDC>
    <NDCCode>66343-052-50</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE (66343-052-50) </PackageDescription>
    <NDC11Code>66343-0052-50</NDC11Code>
    <ProductNDC>66343-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Emvita 3</ProprietaryName>
    <NonProprietaryName>Apis Mellifica, Conium, Oophorinum, Bovista, Hepar Sulph Calc, Orchitinum</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190603</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>RUBIMED AG</LabelerName>
    <SubstanceName>APIS MELLIFERA; CONIUM MACULATUM FLOWERING TOP; SUS SCROFA OVARY; LYCOPERDON UTRIFORME FRUITING BODY; CALCIUM SULFIDE; SUS SCROFA TESTICLE</SubstanceName>
    <StrengthNumber>800; 18; 21; 21; 16; 21</StrengthNumber>
    <StrengthUnit>[hp_C]/50mL; [hp_M]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_M]/50mL; [hp_X]/50mL</StrengthUnit>
    <Pharm_Classes>Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Bee Venoms [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67544-052-50</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE, PLASTIC (67544-052-50)</PackageDescription>
    <NDC11Code>67544-0052-50</NDC11Code>
    <ProductNDC>67544-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Coumadin</ProprietaryName>
    <NonProprietaryName>Warfarin Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA009218</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, Inc.</LabelerName>
    <SubstanceName>WARFARIN SODIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-03-29</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>69844-052-01</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (69844-052-01) </PackageDescription>
    <NDC11Code>69844-0052-01</NDC11Code>
    <ProductNDC>69844-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Furosemide</ProprietaryName>
    <NonProprietaryName>Furosemide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221017</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216629</ApplicationNumber>
    <LabelerName>Graviti Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>FUROSEMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221017</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Edema. Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide Tablets are particularly useful when an agent with greater diuretic potential is desired. Hypertension. Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.</IndicationAndUsage>
    <Description>Furosemide Tablets, USP are a diuretic which is an anthranilic acid derivative. Furosemide tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: lactose monohydrate, corn starch, pregelatinized starch, talc, colloidal silicon dioxide, magnesium stearate. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide tablets are available as white tablets for oral administration in dosage strengths of 20 mg, 40 mg and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Meets USP dissolution test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>70529-052-01</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (70529-052-01)  *  1 mL in 1 VIAL *  1 mL in 1 PACKET *  50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>70529-0052-01</NDC11Code>
    <ProductNDC>70529-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omnitrenidol</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride, Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20181101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088299</ApplicationNumber>
    <LabelerName>IT3 Medical LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2023-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70600-052-01</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (70600-052-01) </PackageDescription>
    <NDC11Code>70600-0052-01</NDC11Code>
    <ProductNDC>70600-052</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Manganese Sulfate Monohydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20240329</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Maithri Drugs Private Limited</LabelerName>
    <SubstanceName>MANGANESE SULFATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-04-11</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>29-MAR-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>70954-052-10</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (70954-052-10) </PackageDescription>
    <NDC11Code>70954-0052-10</NDC11Code>
    <ProductNDC>70954-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250505</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217881</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocortisone tablets are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Non suppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitis. Serum sickness. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic conjunctivitis. Keratitis. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Iritis and iridocyclitis. Chorioretinitis. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. 7. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Hydrocortisone Tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone, USP is white to practically white, odorless, crystalline powder with a melting point of about 215°C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone Tablets, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of Hydrocortisone, USP. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. FDA approved dissolution test and specifications differs from the USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>71447-052-01</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (71447-052-01)  &gt; 50 g in 1 BOTTLE, PLASTIC (71447-052-00) </PackageDescription>
    <NDC11Code>71447-0052-01</NDC11Code>
    <ProductNDC>71447-052</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lani And Kai Mineral Sunscreen</ProprietaryName>
    <ProprietaryNameSuffix>Spf30</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>LABORATOIRES DRUIDE INC</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>2; 18.4</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>▪ Helps prevent sunburn. ▪ If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>21922-052-50</NDCCode><ProprietaryName>Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%</ProprietaryName><NonProprietaryName>Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%</NonProprietaryName></NDC><NDC><NDCCode>21922-015-40</NDCCode><ProprietaryName>Estradiol</ProprietaryName><NonProprietaryName>Estradiol</NonProprietaryName></NDC><NDC><NDCCode>21922-038-14</NDCCode><ProprietaryName>Azelaic Acid Gel</ProprietaryName><NonProprietaryName>Azelaic Acid</NonProprietaryName></NDC><NDC><NDCCode>21922-042-40</NDCCode><ProprietaryName>Tretinoin</ProprietaryName><NonProprietaryName>Tretinoin</NonProprietaryName></NDC><NDC><NDCCode>21922-043-40</NDCCode><ProprietaryName>Tretinoin</ProprietaryName><NonProprietaryName>Tretinoin</NonProprietaryName></NDC><NDC><NDCCode>21922-044-14</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium Topical Gel, 1%</NonProprietaryName></NDC><NDC><NDCCode>21922-051-50</NDCCode><ProprietaryName>Adapalene Gel Usp, 0.3%</ProprietaryName><NonProprietaryName>Adapalene Gel Usp, 0.3%</NonProprietaryName></NDC><NDC><NDCCode>21922-061-27</NDCCode><ProprietaryName>Clobetasol Propionate</ProprietaryName><NonProprietaryName>Clobetasol Propionate</NonProprietaryName></NDC><NDC><NDCCode>21922-074-40</NDCCode><ProprietaryName>Clindamycin Phosphate And Benzoyl Peroxide</ProprietaryName><NonProprietaryName>Clindamycin Phosphate And Benzoyl Peroxide</NonProprietaryName></NDC><NDC><NDCCode>21922-107-61</NDCCode><ProprietaryName>Lidocaine</ProprietaryName><NonProprietaryName>Lidicaine</NonProprietaryName></NDC><NDC><NDCCode>21922-108-14</NDCCode><ProprietaryName>Halobetasol Propionate</ProprietaryName><NonProprietaryName>Halobetasol Propionate</NonProprietaryName></NDC><NDC><NDCCode>11559-052-01</NDCCode><ProprietaryName>Resilience Multi-effect Tri-peptide Face And Neck Creme Broad Spectrum Spf 15</ProprietaryName><NonProprietaryName>Avobenzone, Octisalate, And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>20151-052-02</NDCCode><ProprietaryName>Purifying Oxygenating Serum</ProprietaryName><NonProprietaryName>Glycerin, Dimethicone</NonProprietaryName></NDC><NDC><NDCCode>29033-052-50</NDCCode><ProprietaryName>Doxycycline Hyclate</ProprietaryName><NonProprietaryName>Doxycycline Hyclate</NonProprietaryName></NDC><NDC><NDCCode>42851-158-60</NDCCode><ProprietaryName>Zo Medical Zo Non-hydroquinone Hyperpigmentation System For Skin Brightening</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>42961-052-03</NDCCode><ProprietaryName>Dilotab Ii</ProprietaryName><NonProprietaryName>Acetaminophen Phenylephrine</NonProprietaryName></NDC><NDC><NDCCode>49967-052-03</NDCCode><ProprietaryName>Matrix Biolage Scalpsync Antidandruff</ProprietaryName><NonProprietaryName>Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>50268-052-15</NDCCode><ProprietaryName>Arthritis Pain Reliever</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>51060-052-01</NDCCode><ProprietaryName>Amazonian Clay 12-hour Full Coverage Foundation Broad Spectrum Spf 15 Sunscreen</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>51144-052-81</NDCCode><NonProprietaryName>Brentuximab Vedotin</NonProprietaryName></NDC><NDC><NDCCode>51621-052-02</NDCCode><ProprietaryName>Dr.g Medi Uv Ultra Sun Spf 50 Plus Pa Plus Plus Plus</ProprietaryName><NonProprietaryName>Zinc Oxide And Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>62331-052-31</NDCCode><NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>65162-052-50</NDCCode><ProprietaryName>Citalopram</ProprietaryName><NonProprietaryName>Citalopram</NonProprietaryName></NDC><NDC><NDCCode>66343-052-50</NDCCode><ProprietaryName>Emvita 3</ProprietaryName><NonProprietaryName>Apis Mellifica, Conium, Oophorinum, Bovista, Hepar Sulph Calc, Orchitinum</NonProprietaryName></NDC><NDC><NDCCode>67544-052-50</NDCCode><ProprietaryName>Coumadin</ProprietaryName><NonProprietaryName>Warfarin Sodium</NonProprietaryName></NDC><NDC><NDCCode>69844-052-01</NDCCode><ProprietaryName>Furosemide</ProprietaryName><NonProprietaryName>Furosemide</NonProprietaryName></NDC><NDC><NDCCode>70529-052-01</NDCCode><ProprietaryName>Omnitrenidol</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride, Triamcinolone Acetonide</NonProprietaryName></NDC><NDC><NDCCode>70600-052-01</NDCCode><NonProprietaryName>Manganese Sulfate Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>70954-052-10</NDCCode><ProprietaryName>Hydrocortisone</ProprietaryName><NonProprietaryName>Hydrocortisone</NonProprietaryName></NDC><NDC><NDCCode>71447-052-01</NDCCode><ProprietaryName>Lani And Kai Mineral Sunscreen</ProprietaryName><NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
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      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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