RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "70512-037-10",
      "PackageDescription": "1 TUBE in 1 CARTON (70512-037-10)  > 100 g in 1 TUBE",
      "NDC11Code": "70512-0037-10",
      "ProductNDC": "70512-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desoximetasone Oint 0.05%",
      "NonProprietaryName": "Desoximetasone Oint 0.05%",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200422",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209973",
      "LabelerName": "SOLA Pharmaceuticals",
      "SubstanceName": "DESOXIMETASONE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200422",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70512-037-60",
      "PackageDescription": "1 TUBE in 1 CARTON (70512-037-60)  > 60 g in 1 TUBE",
      "NDC11Code": "70512-0037-60",
      "ProductNDC": "70512-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desoximetasone Oint 0.05%",
      "NonProprietaryName": "Desoximetasone Oint 0.05%",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200422",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209973",
      "LabelerName": "SOLA Pharmaceuticals",
      "SubstanceName": "DESOXIMETASONE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200422",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70512-002-10",
      "PackageDescription": "100 mg in 1 BOTTLE (70512-002-10) ",
      "NDC11Code": "70512-0002-10",
      "ProductNDC": "70512-002",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenazopyridine",
      "NonProprietaryName": "Phenazopyridine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180219",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "SOLA Pharmaceuticals",
      "SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mg",
      "Status": "Deprecated",
      "LastUpdate": "2018-03-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180219",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70512-003-10",
      "PackageDescription": "200 mg in 1 BOTTLE (70512-003-10) ",
      "NDC11Code": "70512-0003-10",
      "ProductNDC": "70512-003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenazopyridine",
      "NonProprietaryName": "Phenazopyridine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180219",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "SOLA Pharmaceuticals",
      "SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/mg",
      "Status": "Deprecated",
      "LastUpdate": "2018-03-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180219",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "70512-016-10",
      "PackageDescription": "10 POUCH in 1 BOX (70512-016-10)  / 9 g in 1 POUCH",
      "NDC11Code": "70512-0016-10",
      "ProductNDC": "70512-016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Capsimide",
      "NonProprietaryName": "Capsaicin 0.025% Topical Patch",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220907",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Sola Pharmaceuticals",
      "SubstanceName": "CAPSAICIN",
      "StrengthNumber": ".025",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220907",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves minor pain."
    },
    {
      "NDCCode": "70512-106-10",
      "PackageDescription": "1 TUBE in 1 CARTON (70512-106-10)  / 100 g in 1 TUBE",
      "NDC11Code": "70512-0106-10",
      "ProductNDC": "70512-106",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Diclofenac Sodium",
      "NonProprietaryName": "Diclofenac Sodium 1%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210317",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210986",
      "LabelerName": "SOLA Pharmaceuticals",
      "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": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210317",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 for the temporary relief of arthritis pain ONLY in the following areas: ."
    },
    {
      "NDCCode": "70512-750-10",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-10) ",
      "NDC11Code": "70512-0750-10",
      "ProductNDC": "70512-750",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac Potassium",
      "NonProprietaryName": "Diclofenac Potassium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241021",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215787",
      "LabelerName": "SOLA Pharmaceuticals, LLC",
      "SubstanceName": "DICLOFENAC POTASSIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241021",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 for treatment of primary dysmenorrhea, 2 for relief of mild to moderate pain, 3 for relief of the signs and symptoms of osteoarthritis , 4 for relief of the signs and symptoms of rheumatoid arthritis .",
      "Description": "Diclofenac potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets are available for oral administration. Diclofenac potassium, USP is a white to off-white or slightly yellowish crystalline powder, slightly hygroscopic and is sparingly soluble in water, Freely soluble in methanol; soluble in alcohol, slightly soluble in acetone. The chemical name is Potassium [ o-(2,6-dichloroanilino)phenyl] acetate. The molecular weight is 334.24. Its molecular formula is C 14H 10Cl 2KNO 2, and it has the following structural formula:. The inactive ingredients in diclofenac potassium tablets include: Lactose Anhydrous, Microcrystalline Cellulose, NF, Colloidal Silicon Dioxide, NF, Croscarmellose Sodium, NF, Magnesium Stearate, NF, Titanium Dioxide, USP, Polydextrose, NF, Hypromellose, USP 2910 (6 mPas), Hypromellose, USP 2910 (3 mPas), Hypromellose, USP 2910 (50 mPas), Triacetin, USP and Polyethylene Glycol, NF 8000."
    },
    {
      "NDCCode": "70512-780-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE (70512-780-10) ",
      "NDC11Code": "70512-0780-10",
      "ProductNDC": "70512-780",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078329",
      "LabelerName": "SOLA Pharmaceuticals, LLC",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "800",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
      "Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - ( p- isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), is available in 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate, Opadry II contains hypromellose, polyethylene glycol, sodium citrate, lactose monohydrate and titanium dioxide."
    },
    {
      "NDCCode": "70512-782-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (70512-782-10) ",
      "NDC11Code": "70512-0782-10",
      "ProductNDC": "70512-782",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Baclofen",
      "NonProprietaryName": "Baclofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250321",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209102",
      "LabelerName": "SOLA Pharmaceuticals, LLC",
      "SubstanceName": "BACLOFEN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250321",
      "SamplePackage": "N",
      "IndicationAndUsage": "Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
      "Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C 10H 12ClNO 2                M.W.213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 10 mg baclofen, USP In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate."
    },
    {
      "NDCCode": "70512-790-10",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (70512-790-10)  / 10 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "70512-0790-10",
      "ProductNDC": "70512-790",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketorolac Tromethamine",
      "NonProprietaryName": "Ketorolac Tromethamine",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20240415",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA218204",
      "LabelerName": "SOLA Pharmaceuticals, LLC",
      "SubstanceName": "KETOROLAC TROMETHAMINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240415",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.",
      "Description": "Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2, 3-dihydro-1H pyrrolizine-1-carboxylic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure. Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution is a racemic mixture of R-(+) and S-(-) -ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution contains: Active:ketorolac tromethamine 0.5%. Preservative:benzalkonium chloride 0.01%. Inactives:edetate disodium 0.1%; octoxynol 40; water for injection; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH."
    },
    {
      "NDCCode": "70512-793-10",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (70512-793-10)  / 10 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "70512-0793-10",
      "ProductNDC": "70512-793",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ofloxacin",
      "NonProprietaryName": "Ofloxacin Ophthalmic Solution Usp, 0.3%",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20240430",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217904",
      "LabelerName": "SOLA Pharmaceuticals, LLC",
      "SubstanceName": "OFLOXACIN",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240430",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below.",
      "Description": "Ofloxacin Ophthalmic Solution USP 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name. (±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H-pyrido[1,2,3- de]-1,4-benzoxazine-6-carboxylic acid. Contains: Active:ofloxacin 0.3% (3 mg/mL). Preservative:benzalkonium chloride (0.005%). Inactives:sodium chloride and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin Ophthalmic Solution USP, 0.3%is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure."
    },
    {
      "NDCCode": "70512-841-11",
      "PackageDescription": "70 BAG in 1 CARTON (70512-841-11)  / 100 mL in 1 BAG (70512-841-10) ",
      "NDC11Code": "70512-0841-11",
      "ProductNDC": "70512-841",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170525",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207956",
      "LabelerName": "SOLA Pharmaceuticals, LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "9",
      "StrengthUnit": "g/1000mL",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.",
      "Description": "Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH ranges from 4.5 to 7.0. Composition, osmolarity, and ionic concentration are shown below. 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container materials has been established through biological evaluations, which have shown the containers pass Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container systems."
    },
    {
      "NDCCode": "70512-841-61",
      "PackageDescription": "10 BAG in 1 CARTON (70512-841-61)  / 1000 mL in 1 BAG (70512-841-60) ",
      "NDC11Code": "70512-0841-61",
      "ProductNDC": "70512-841",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170525",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207956",
      "LabelerName": "SOLA Pharmaceuticals, LLC",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "9",
      "StrengthUnit": "g/1000mL",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.",
      "Description": "Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH ranges from 4.5 to 7.0. Composition, osmolarity, and ionic concentration are shown below. 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container materials has been established through biological evaluations, which have shown the containers pass Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container systems."
    },
    {
      "NDCCode": "70512-872-10",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (70512-872-10) ",
      "NDC11Code": "70512-0872-10",
      "ProductNDC": "70512-872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077563",
      "LabelerName": "SOLA Pharmaceuticals, LLC",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250731",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25° C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene) -N ,N -dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP for oral administration, are available in the following strengths, 5 mg, 7.5 mg and 10 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg tablet contain FD&C yellow #6, and both the 5 mg and 10 mg tablets contain iron oxide yellow."
    },
    {
      "NDCCode": "81877-512-10",
      "PackageDescription": "1 KIT in 1 PACKAGE (81877-512-10)  *  1 TUBE in 1 CARTON (70512-106-10)  > 100 g in 1 TUBE",
      "NDC11Code": "81877-0512-10",
      "ProductNDC": "81877-512",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dicloprep-100",
      "NonProprietaryName": "Diclofenac Sodium, Isopropyl Alcohol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20211220",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Forreal Pharmaceuticals LLC",
      "Status": "Deprecated",
      "LastUpdate": "2022-09-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20211220",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "82226-020-10",
      "PackageDescription": "1 KIT in 1 PACKAGE (82226-020-10)  *  1 TUBE in 1 CARTON (70512-106-10)  > 100 g in 1 TUBE",
      "NDC11Code": "82226-0020-10",
      "ProductNDC": "82226-020",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Valcoprep-100",
      "NonProprietaryName": "Diclofenac Sodium, Isopropyl Alcohol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20210317",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210986",
      "LabelerName": "Plum Valley Pharma LLC",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210317",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10695-037-11",
      "PackageDescription": "10 g in 1 BOTTLE (10695-037-11)",
      "NDC11Code": "10695-0037-11",
      "ProductNDC": "10695-037",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Epinephrine",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170317",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Willow Birch Pharma, Inc.",
      "SubstanceName": "EPINEPHRINE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "12707-037-01",
      "PackageDescription": "10 g in 1 DRUM (12707-037-01) ",
      "NDC11Code": "12707-0037-01",
      "ProductNDC": "12707-037",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Naloxone Hydrochloride Dihydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20171211",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Macfarlan Smith Limited",
      "SubstanceName": "NALOXONE HYDROCHLORIDE DIHYDRATE",
      "StrengthNumber": "100",
      "StrengthUnit": "g/100g",
      "Status": "Unfinished",
      "LastUpdate": "2026-02-25",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "11-DEC-17"
    },
    {
      "NDCCode": "16714-037-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (16714-037-10)  / 1 mL in 1 VIAL, SINGLE-DOSE (16714-037-01) ",
      "NDC11Code": "16714-0037-10",
      "ProductNDC": "16714-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ephedrine Sulfate",
      "NonProprietaryName": "Ephedrine Sulfate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201202",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212932",
      "LabelerName": "NorthStar Rx LLC",
      "SubstanceName": "EPHEDRINE SULFATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-01-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201202",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.",
      "Description": "Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine sulfate injection, USP is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate, and the molecular weight is 428.5 g/mol. Its molecular formula is (C10H15NO)2.H2SO4 and structural formula is depicted below. Ephedrine sulfate, USP is a white to off-white powder; it is freely soluble in water and slightly soluble in alcohol. Each mL contains ephedrine sulfate, USP 50 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0."
    },
    {
      "NDCCode": "21695-037-10",
      "PackageDescription": "10 TABLET in 1 BOTTLE (21695-037-10)",
      "NDC11Code": "21695-0037-10",
      "ProductNDC": "21695-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078218",
      "LabelerName": "Rebel Distributors",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20H21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets 10 mg contain the following inactive ingredients: croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, and titanium dioxide."
    },
    {
      "NDCCode": "42507-037-10",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (42507-037-10)  > 30 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "42507-0037-10",
      "ProductNDC": "42507-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nasal",
      "NonProprietaryName": "Oxymetazoline Hydrochloride",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20160812",
      "EndMarketingDate": "20190219",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "HyVee Inc",
      "SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-02-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160812",
      "EndMarketingDatePackage": "20190219",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50242-120-47",
      "PackageDescription": "1 KIT in 1 CARTON (50242-120-47)  *  1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06)  / 10 mL in 1 VIAL, SINGLE-USE *  1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09)  / 10 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "50242-0120-47",
      "ProductNDC": "50242-120",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tnkase",
      "NonProprietaryName": "Tenecteplase",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20181107",
      "EndMarketingDate": "20270131",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103909",
      "LabelerName": "Genentech, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20181107",
      "EndMarketingDatePackage": "20270131",
      "SamplePackage": "N",
      "IndicationAndUsage": "TNKase® is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI).",
      "Description": "Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3."
    },
    {
      "NDCCode": "50242-176-01",
      "PackageDescription": "1 KIT in 1 CARTON (50242-176-01)  *  1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06)  / 10 mL in 1 VIAL, SINGLE-USE *  1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09)  / 10 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "50242-0176-01",
      "ProductNDC": "50242-176",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tnkase",
      "NonProprietaryName": "Tenecteplase",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240105",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA103909",
      "LabelerName": "Genentech, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240105",
      "SamplePackage": "N",
      "IndicationAndUsage": "TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).",
      "Description": "Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3."
    },
    {
      "NDCCode": "51621-037-01",
      "PackageDescription": "10 mL in 1 CARTON (51621-037-01)",
      "NDC11Code": "51621-0037-01",
      "ProductNDC": "51621-037",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr.g Dewrinkle Booster Ample",
      "ProprietaryNameSuffix": "By Egf",
      "NonProprietaryName": "Glycerin",
      "DosageFormName": "CREAM",
      "RouteName": "CUTANEOUS",
      "StartMarketingDate": "20100601",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "GOWOONSESANG COSMETICS CO., LTD.",
      "SubstanceName": "GLYCERIN; DIMETHICONE",
      "StrengthNumber": "2; .1",
      "StrengthUnit": "mL/10mL; mL/10mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-23",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "52584-037-10",
      "PackageDescription": "1 VIAL in 1 BAG (52584-037-10)  > 20 mL in 1 VIAL",
      "NDC11Code": "52584-0037-10",
      "ProductNDC": "52584-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketalar",
      "NonProprietaryName": "Ketamine Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20121017",
      "EndMarketingDate": "20250228",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016812",
      "LabelerName": "General Injectables & Vaccines, Inc",
      "SubstanceName": "KETAMINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20121017",
      "EndMarketingDatePackage": "20250228",
      "SamplePackage": "N",
      "IndicationAndUsage": "KETALAR (ketamine hydrochloride) injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.",
      "Description": "KETALAR (ketamine hydrochloride) injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. ketamine hydrochloride. It is formulated as a slightly acidic (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride."
    },
    {
      "NDCCode": "54879-037-25",
      "PackageDescription": "25 VIAL, GLASS in 1 CARTON (54879-037-25)  > 10 mL in 1 VIAL, GLASS (54879-037-10) ",
      "NDC11Code": "54879-0037-25",
      "ProductNDC": "54879-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Succinylcholine Chloride",
      "NonProprietaryName": "Succinylcholine Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20201103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214308",
      "LabelerName": "STI Pharma LLC",
      "SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20201103",
      "SamplePackage": "N",
      "IndicationAndUsage": "Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation.",
      "Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C 14H 30Cl 2N 2O 4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:. Succinylcholine Chloride Injection 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.70 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
    },
    {
      "NDCCode": "54879-037-50",
      "PackageDescription": "50 VIAL, GLASS in 1 CARTON (54879-037-50)  > 10 mL in 1 VIAL, GLASS (54879-037-10) ",
      "NDC11Code": "54879-0037-50",
      "ProductNDC": "54879-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Succinylcholine Chloride",
      "NonProprietaryName": "Succinylcholine Chloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20201103",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214308",
      "LabelerName": "STI Pharma LLC",
      "SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20210412",
      "SamplePackage": "N",
      "IndicationAndUsage": "Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation.",
      "Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C 14H 30Cl 2N 2O 4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:. Succinylcholine Chloride Injection 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.70 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.)."
    },
    {
      "NDCCode": "55390-037-10",
      "PackageDescription": "10 VIAL in 1 BOX (55390-037-10)  > 10 mL in 1 VIAL",
      "NDC11Code": "55390-0037-10",
      "ProductNDC": "55390-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vecuronium Bromide",
      "NonProprietaryName": "Vecuronium Bromide",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20000801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075549",
      "LabelerName": "Bedford Laboratories",
      "SubstanceName": "VECURONIUM BROMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-04-22"
    },
    {
      "NDCCode": "58159-037-04",
      "PackageDescription": "10 kg in 1 DRUM (58159-037-04) ",
      "NDC11Code": "58159-0037-04",
      "ProductNDC": "58159-037",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Nitisinone",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20241209",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "NITISINONE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-12-19",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "09-DEC-24"
    },
    {
      "NDCCode": "60592-037-10",
      "PackageDescription": "1 g in 1 BOTTLE (60592-037-10) ",
      "NDC11Code": "60592-0037-10",
      "ProductNDC": "60592-037",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Levamisol Hcl",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20191224",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Kalchem International inc",
      "SubstanceName": "LEVAMISOLE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2025-10-06",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "24-DEC-19"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"70512-037-10","ProprietaryName":"Desoximetasone Oint 0.05%","NonProprietaryName":"Desoximetasone Oint 0.05%"},{"NDCCode":"70512-037-60","ProprietaryName":"Desoximetasone Oint 0.05%","NonProprietaryName":"Desoximetasone Oint 0.05%"},{"NDCCode":"70512-002-10","ProprietaryName":"Phenazopyridine","NonProprietaryName":"Phenazopyridine"},{"NDCCode":"70512-003-10","ProprietaryName":"Phenazopyridine","NonProprietaryName":"Phenazopyridine"},{"NDCCode":"70512-016-10","ProprietaryName":"Capsimide","NonProprietaryName":"Capsaicin 0.025% Topical Patch"},{"NDCCode":"70512-106-10","ProprietaryName":"Diclofenac Sodium","NonProprietaryName":"Diclofenac Sodium 1%"},{"NDCCode":"70512-750-10","ProprietaryName":"Diclofenac Potassium","NonProprietaryName":"Diclofenac Potassium"},{"NDCCode":"70512-780-10","ProprietaryName":"Ibuprofen","NonProprietaryName":"Ibuprofen"},{"NDCCode":"70512-782-10","ProprietaryName":"Baclofen","NonProprietaryName":"Baclofen"},{"NDCCode":"70512-790-10","ProprietaryName":"Ketorolac Tromethamine","NonProprietaryName":"Ketorolac Tromethamine"},{"NDCCode":"70512-793-10","ProprietaryName":"Ofloxacin","NonProprietaryName":"Ofloxacin Ophthalmic Solution Usp, 0.3%"},{"NDCCode":"70512-841-11","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"70512-841-61","ProprietaryName":"Sodium Chloride","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"70512-872-10","ProprietaryName":"Cyclobenzaprine Hydrochloride","NonProprietaryName":"Cyclobenzaprine Hydrochloride"},{"NDCCode":"81877-512-10","ProprietaryName":"Dicloprep-100","NonProprietaryName":"Diclofenac Sodium, Isopropyl Alcohol"},{"NDCCode":"82226-020-10","ProprietaryName":"Valcoprep-100","NonProprietaryName":"Diclofenac Sodium, Isopropyl Alcohol"},{"NDCCode":"10695-037-11","NonProprietaryName":"Epinephrine"},{"NDCCode":"12707-037-01","NonProprietaryName":"Naloxone Hydrochloride Dihydrate"},{"NDCCode":"16714-037-10","ProprietaryName":"Ephedrine Sulfate","NonProprietaryName":"Ephedrine Sulfate"},{"NDCCode":"21695-037-10","ProprietaryName":"Cyclobenzaprine Hydrochloride","NonProprietaryName":"Cyclobenzaprine Hydrochloride"},{"NDCCode":"42507-037-10","ProprietaryName":"Nasal","NonProprietaryName":"Oxymetazoline Hydrochloride"},{"NDCCode":"50242-120-47","ProprietaryName":"Tnkase","NonProprietaryName":"Tenecteplase"},{"NDCCode":"50242-176-01","ProprietaryName":"Tnkase","NonProprietaryName":"Tenecteplase"},{"NDCCode":"51621-037-01","ProprietaryName":"Dr.g Dewrinkle Booster Ample","NonProprietaryName":"Glycerin"},{"NDCCode":"52584-037-10","ProprietaryName":"Ketalar","NonProprietaryName":"Ketamine Hydrochloride"},{"NDCCode":"54879-037-25","ProprietaryName":"Succinylcholine Chloride","NonProprietaryName":"Succinylcholine Chloride"},{"NDCCode":"54879-037-50","ProprietaryName":"Succinylcholine Chloride","NonProprietaryName":"Succinylcholine Chloride"},{"NDCCode":"55390-037-10","ProprietaryName":"Vecuronium Bromide","NonProprietaryName":"Vecuronium Bromide"},{"NDCCode":"58159-037-04","NonProprietaryName":"Nitisinone"},{"NDCCode":"60592-037-10","NonProprietaryName":"Levamisol Hcl"}]}
                    

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    <NDCCode>70512-037-10</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (70512-037-10)  &gt; 100 g in 1 TUBE</PackageDescription>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desoximetasone Oint 0.05%</ProprietaryName>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
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    <SubstanceName>DESOXIMETASONE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
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    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <NDCCode>70512-037-60</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (70512-037-60)  &gt; 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>70512-0037-60</NDC11Code>
    <ProductNDC>70512-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desoximetasone Oint 0.05%</ProprietaryName>
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    <DosageFormName>OINTMENT</DosageFormName>
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    <SubstanceName>DESOXIMETASONE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
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    <LastUpdate>2022-12-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200422</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>70512-002-10</NDCCode>
    <PackageDescription>100 mg in 1 BOTTLE (70512-002-10) </PackageDescription>
    <NDC11Code>70512-0002-10</NDC11Code>
    <ProductNDC>70512-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenazopyridine</ProprietaryName>
    <NonProprietaryName>Phenazopyridine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180219</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>SOLA Pharmaceuticals</LabelerName>
    <SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180219</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70512-003-10</NDCCode>
    <PackageDescription>200 mg in 1 BOTTLE (70512-003-10) </PackageDescription>
    <NDC11Code>70512-0003-10</NDC11Code>
    <ProductNDC>70512-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenazopyridine</ProprietaryName>
    <NonProprietaryName>Phenazopyridine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180219</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>SOLA Pharmaceuticals</LabelerName>
    <SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180219</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70512-016-10</NDCCode>
    <PackageDescription>10 POUCH in 1 BOX (70512-016-10)  / 9 g in 1 POUCH</PackageDescription>
    <NDC11Code>70512-0016-10</NDC11Code>
    <ProductNDC>70512-016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Capsimide</ProprietaryName>
    <NonProprietaryName>Capsaicin 0.025% Topical Patch</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220907</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Sola Pharmaceuticals</LabelerName>
    <SubstanceName>CAPSAICIN</SubstanceName>
    <StrengthNumber>.025</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220907</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves minor pain.</IndicationAndUsage>
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  <NDC>
    <NDCCode>70512-106-10</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (70512-106-10)  / 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>70512-0106-10</NDC11Code>
    <ProductNDC>70512-106</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium 1%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210317</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210986</ApplicationNumber>
    <LabelerName>SOLA Pharmaceuticals</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>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 for the temporary relief of arthritis pain ONLY in the following areas: .</IndicationAndUsage>
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  <NDC>
    <NDCCode>70512-750-10</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-10) </PackageDescription>
    <NDC11Code>70512-0750-10</NDC11Code>
    <ProductNDC>70512-750</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Potassium</ProprietaryName>
    <NonProprietaryName>Diclofenac Potassium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241021</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215787</ApplicationNumber>
    <LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>DICLOFENAC POTASSIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</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>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 for treatment of primary dysmenorrhea, 2 for relief of mild to moderate pain, 3 for relief of the signs and symptoms of osteoarthritis , 4 for relief of the signs and symptoms of rheumatoid arthritis .</IndicationAndUsage>
    <Description>Diclofenac potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets are available for oral administration. Diclofenac potassium, USP is a white to off-white or slightly yellowish crystalline powder, slightly hygroscopic and is sparingly soluble in water, Freely soluble in methanol; soluble in alcohol, slightly soluble in acetone. The chemical name is Potassium [ o-(2,6-dichloroanilino)phenyl] acetate. The molecular weight is 334.24. Its molecular formula is C 14H 10Cl 2KNO 2, and it has the following structural formula:. The inactive ingredients in diclofenac potassium tablets include: Lactose Anhydrous, Microcrystalline Cellulose, NF, Colloidal Silicon Dioxide, NF, Croscarmellose Sodium, NF, Magnesium Stearate, NF, Titanium Dioxide, USP, Polydextrose, NF, Hypromellose, USP 2910 (6 mPas), Hypromellose, USP 2910 (3 mPas), Hypromellose, USP 2910 (50 mPas), Triacetin, USP and Polyethylene Glycol, NF 8000.</Description>
  </NDC>
  <NDC>
    <NDCCode>70512-780-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (70512-780-10) </PackageDescription>
    <NDC11Code>70512-0780-10</NDC11Code>
    <ProductNDC>70512-780</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078329</ApplicationNumber>
    <LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - ( p- isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), is available in 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate, Opadry II contains hypromellose, polyethylene glycol, sodium citrate, lactose monohydrate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>70512-782-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (70512-782-10) </PackageDescription>
    <NDC11Code>70512-0782-10</NDC11Code>
    <ProductNDC>70512-782</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Baclofen</ProprietaryName>
    <NonProprietaryName>Baclofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250321</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209102</ApplicationNumber>
    <LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>BACLOFEN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250321</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
    <Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C 10H 12ClNO 2                M.W.213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 10 mg baclofen, USP In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70512-790-10</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (70512-790-10)  / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>70512-0790-10</NDC11Code>
    <ProductNDC>70512-790</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240415</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218204</ApplicationNumber>
    <LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.</IndicationAndUsage>
    <Description>Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2, 3-dihydro-1H pyrrolizine-1-carboxylic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure. Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution is a racemic mixture of R-(+) and S-(-) -ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution contains: Active:ketorolac tromethamine 0.5%. Preservative:benzalkonium chloride 0.01%. Inactives:edetate disodium 0.1%; octoxynol 40; water for injection; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>70512-793-10</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 BOX (70512-793-10)  / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>70512-0793-10</NDC11Code>
    <ProductNDC>70512-793</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ofloxacin</ProprietaryName>
    <NonProprietaryName>Ofloxacin Ophthalmic Solution Usp, 0.3%</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240430</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217904</ApplicationNumber>
    <LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>OFLOXACIN</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below.</IndicationAndUsage>
    <Description>Ofloxacin Ophthalmic Solution USP 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name. (±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H-pyrido[1,2,3- de]-1,4-benzoxazine-6-carboxylic acid. Contains: Active:ofloxacin 0.3% (3 mg/mL). Preservative:benzalkonium chloride (0.005%). Inactives:sodium chloride and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin Ophthalmic Solution USP, 0.3%is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.</Description>
  </NDC>
  <NDC>
    <NDCCode>70512-841-11</NDCCode>
    <PackageDescription>70 BAG in 1 CARTON (70512-841-11)  / 100 mL in 1 BAG (70512-841-10) </PackageDescription>
    <NDC11Code>70512-0841-11</NDC11Code>
    <ProductNDC>70512-841</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170525</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207956</ApplicationNumber>
    <LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>g/1000mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.</IndicationAndUsage>
    <Description>Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH ranges from 4.5 to 7.0. Composition, osmolarity, and ionic concentration are shown below. 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container materials has been established through biological evaluations, which have shown the containers pass Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container systems.</Description>
  </NDC>
  <NDC>
    <NDCCode>70512-841-61</NDCCode>
    <PackageDescription>10 BAG in 1 CARTON (70512-841-61)  / 1000 mL in 1 BAG (70512-841-60) </PackageDescription>
    <NDC11Code>70512-0841-61</NDC11Code>
    <ProductNDC>70512-841</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20170525</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207956</ApplicationNumber>
    <LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>g/1000mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.</IndicationAndUsage>
    <Description>Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH ranges from 4.5 to 7.0. Composition, osmolarity, and ionic concentration are shown below. 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container materials has been established through biological evaluations, which have shown the containers pass Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container systems.</Description>
  </NDC>
  <NDC>
    <NDCCode>70512-872-10</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (70512-872-10) </PackageDescription>
    <NDC11Code>70512-0872-10</NDC11Code>
    <ProductNDC>70512-872</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077563</ApplicationNumber>
    <LabelerName>SOLA Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25° C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine Hydrochloride is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene) -N ,N -dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP for oral administration, are available in the following strengths, 5 mg, 7.5 mg and 10 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg tablet contain FD&amp;C yellow #6, and both the 5 mg and 10 mg tablets contain iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>81877-512-10</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (81877-512-10)  *  1 TUBE in 1 CARTON (70512-106-10)  &gt; 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>81877-0512-10</NDC11Code>
    <ProductNDC>81877-512</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dicloprep-100</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium, Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20211220</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Forreal Pharmaceuticals LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-09-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>82226-020-10</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (82226-020-10)  *  1 TUBE in 1 CARTON (70512-106-10)  &gt; 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>82226-0020-10</NDC11Code>
    <ProductNDC>82226-020</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valcoprep-100</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium, Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20210317</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210986</ApplicationNumber>
    <LabelerName>Plum Valley Pharma LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>10695-037-11</NDCCode>
    <PackageDescription>10 g in 1 BOTTLE (10695-037-11)</PackageDescription>
    <NDC11Code>10695-0037-11</NDC11Code>
    <ProductNDC>10695-037</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Epinephrine</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170317</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Willow Birch Pharma, Inc.</LabelerName>
    <SubstanceName>EPINEPHRINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>12707-037-01</NDCCode>
    <PackageDescription>10 g in 1 DRUM (12707-037-01) </PackageDescription>
    <NDC11Code>12707-0037-01</NDC11Code>
    <ProductNDC>12707-037</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Naloxone Hydrochloride Dihydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20171211</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Macfarlan Smith Limited</LabelerName>
    <SubstanceName>NALOXONE HYDROCHLORIDE DIHYDRATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-02-25</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-DEC-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>16714-037-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (16714-037-10)  / 1 mL in 1 VIAL, SINGLE-DOSE (16714-037-01) </PackageDescription>
    <NDC11Code>16714-0037-10</NDC11Code>
    <ProductNDC>16714-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ephedrine Sulfate</ProprietaryName>
    <NonProprietaryName>Ephedrine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212932</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>EPHEDRINE SULFATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.</IndicationAndUsage>
    <Description>Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine sulfate injection, USP is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate, and the molecular weight is 428.5 g/mol. Its molecular formula is (C10H15NO)2.H2SO4 and structural formula is depicted below. Ephedrine sulfate, USP is a white to off-white powder; it is freely soluble in water and slightly soluble in alcohol. Each mL contains ephedrine sulfate, USP 50 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>21695-037-10</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE (21695-037-10)</PackageDescription>
    <NDC11Code>21695-0037-10</NDC11Code>
    <ProductNDC>21695-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078218</ApplicationNumber>
    <LabelerName>Rebel Distributors</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20H21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets 10 mg contain the following inactive ingredients: croscarmellose sodium, D&amp;C Yellow #10 aluminum lake, FD&amp;C Blue #2 aluminum lake, FD&amp;C Yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42507-037-10</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (42507-037-10)  &gt; 30 mL in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>42507-0037-10</NDC11Code>
    <ProductNDC>42507-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nasal</ProprietaryName>
    <NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20160812</StartMarketingDate>
    <EndMarketingDate>20190219</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>HyVee Inc</LabelerName>
    <SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20160812</StartMarketingDatePackage>
    <EndMarketingDatePackage>20190219</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50242-120-47</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (50242-120-47)  *  1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06)  / 10 mL in 1 VIAL, SINGLE-USE *  1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09)  / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>50242-0120-47</NDC11Code>
    <ProductNDC>50242-120</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tnkase</ProprietaryName>
    <NonProprietaryName>Tenecteplase</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20181107</StartMarketingDate>
    <EndMarketingDate>20270131</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103909</ApplicationNumber>
    <LabelerName>Genentech, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20181107</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TNKase® is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI).</IndicationAndUsage>
    <Description>Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3.</Description>
  </NDC>
  <NDC>
    <NDCCode>50242-176-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (50242-176-01)  *  1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06)  / 10 mL in 1 VIAL, SINGLE-USE *  1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09)  / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>50242-0176-01</NDC11Code>
    <ProductNDC>50242-176</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tnkase</ProprietaryName>
    <NonProprietaryName>Tenecteplase</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20240105</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103909</ApplicationNumber>
    <LabelerName>Genentech, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).</IndicationAndUsage>
    <Description>Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3.</Description>
  </NDC>
  <NDC>
    <NDCCode>51621-037-01</NDCCode>
    <PackageDescription>10 mL in 1 CARTON (51621-037-01)</PackageDescription>
    <NDC11Code>51621-0037-01</NDC11Code>
    <ProductNDC>51621-037</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dr.g Dewrinkle Booster Ample</ProprietaryName>
    <ProprietaryNameSuffix>By Egf</ProprietaryNameSuffix>
    <NonProprietaryName>Glycerin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>CUTANEOUS</RouteName>
    <StartMarketingDate>20100601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>GOWOONSESANG COSMETICS CO., LTD.</LabelerName>
    <SubstanceName>GLYCERIN; DIMETHICONE</SubstanceName>
    <StrengthNumber>2; .1</StrengthNumber>
    <StrengthUnit>mL/10mL; mL/10mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-23</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>52584-037-10</NDCCode>
    <PackageDescription>1 VIAL in 1 BAG (52584-037-10)  &gt; 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>52584-0037-10</NDC11Code>
    <ProductNDC>52584-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketalar</ProprietaryName>
    <NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20121017</StartMarketingDate>
    <EndMarketingDate>20250228</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA016812</ApplicationNumber>
    <LabelerName>General Injectables &amp; Vaccines, Inc</LabelerName>
    <SubstanceName>KETAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20121017</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KETALAR (ketamine hydrochloride) injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.</IndicationAndUsage>
    <Description>KETALAR (ketamine hydrochloride) injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. ketamine hydrochloride. It is formulated as a slightly acidic (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride.</Description>
  </NDC>
  <NDC>
    <NDCCode>54879-037-25</NDCCode>
    <PackageDescription>25 VIAL, GLASS in 1 CARTON (54879-037-25)  &gt; 10 mL in 1 VIAL, GLASS (54879-037-10) </PackageDescription>
    <NDC11Code>54879-0037-25</NDC11Code>
    <ProductNDC>54879-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Succinylcholine Chloride</ProprietaryName>
    <NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20201103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214308</ApplicationNumber>
    <LabelerName>STI Pharma LLC</LabelerName>
    <SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation.</IndicationAndUsage>
    <Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C 14H 30Cl 2N 2O 4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:. Succinylcholine Chloride Injection 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.70 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
  </NDC>
  <NDC>
    <NDCCode>54879-037-50</NDCCode>
    <PackageDescription>50 VIAL, GLASS in 1 CARTON (54879-037-50)  &gt; 10 mL in 1 VIAL, GLASS (54879-037-10) </PackageDescription>
    <NDC11Code>54879-0037-50</NDC11Code>
    <ProductNDC>54879-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Succinylcholine Chloride</ProprietaryName>
    <NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20201103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214308</ApplicationNumber>
    <LabelerName>STI Pharma LLC</LabelerName>
    <SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Succinylcholine Chloride Injection is indicated in adults and pediatric patients: 1 as an adjunct to general anesthesia, 2 to facilitate tracheal intubation.</IndicationAndUsage>
    <Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine Chloride Injection contains succinylcholine chloride as the active pharmaceutical ingredient. Succinylcholine Chloride, USP is chemically designated C 14H 30Cl 2N 2O 4 and its molecular weight is 361.31. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula:. Succinylcholine Chloride Injection 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of Succinylcholine Chloride Injection 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine anhydrous (equivalent to 22.65 mg of Succinylcholine Chloride, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.70 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.).</Description>
  </NDC>
  <NDC>
    <NDCCode>55390-037-10</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (55390-037-10)  &gt; 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>55390-0037-10</NDC11Code>
    <ProductNDC>55390-037</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vecuronium Bromide</ProprietaryName>
    <NonProprietaryName>Vecuronium Bromide</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20000801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075549</ApplicationNumber>
    <LabelerName>Bedford Laboratories</LabelerName>
    <SubstanceName>VECURONIUM BROMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-04-22</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>58159-037-04</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (58159-037-04) </PackageDescription>
    <NDC11Code>58159-0037-04</NDC11Code>
    <ProductNDC>58159-037</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nitisinone</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20241209</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>NITISINONE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>09-DEC-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>60592-037-10</NDCCode>
    <PackageDescription>1 g in 1 BOTTLE (60592-037-10) </PackageDescription>
    <NDC11Code>60592-0037-10</NDC11Code>
    <ProductNDC>60592-037</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Levamisol Hcl</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20191224</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Kalchem International inc</LabelerName>
    <SubstanceName>LEVAMISOLE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-10-06</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>24-DEC-19</StartMarketingDatePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>70512-037-10</NDCCode><ProprietaryName>Desoximetasone Oint 0.05%</ProprietaryName><NonProprietaryName>Desoximetasone Oint 0.05%</NonProprietaryName></NDC><NDC><NDCCode>70512-037-60</NDCCode><ProprietaryName>Desoximetasone Oint 0.05%</ProprietaryName><NonProprietaryName>Desoximetasone Oint 0.05%</NonProprietaryName></NDC><NDC><NDCCode>70512-002-10</NDCCode><ProprietaryName>Phenazopyridine</ProprietaryName><NonProprietaryName>Phenazopyridine</NonProprietaryName></NDC><NDC><NDCCode>70512-003-10</NDCCode><ProprietaryName>Phenazopyridine</ProprietaryName><NonProprietaryName>Phenazopyridine</NonProprietaryName></NDC><NDC><NDCCode>70512-016-10</NDCCode><ProprietaryName>Capsimide</ProprietaryName><NonProprietaryName>Capsaicin 0.025% Topical Patch</NonProprietaryName></NDC><NDC><NDCCode>70512-106-10</NDCCode><ProprietaryName>Diclofenac Sodium</ProprietaryName><NonProprietaryName>Diclofenac Sodium 1%</NonProprietaryName></NDC><NDC><NDCCode>70512-750-10</NDCCode><ProprietaryName>Diclofenac Potassium</ProprietaryName><NonProprietaryName>Diclofenac Potassium</NonProprietaryName></NDC><NDC><NDCCode>70512-780-10</NDCCode><ProprietaryName>Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>70512-782-10</NDCCode><ProprietaryName>Baclofen</ProprietaryName><NonProprietaryName>Baclofen</NonProprietaryName></NDC><NDC><NDCCode>70512-790-10</NDCCode><ProprietaryName>Ketorolac Tromethamine</ProprietaryName><NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName></NDC><NDC><NDCCode>70512-793-10</NDCCode><ProprietaryName>Ofloxacin</ProprietaryName><NonProprietaryName>Ofloxacin Ophthalmic Solution Usp, 0.3%</NonProprietaryName></NDC><NDC><NDCCode>70512-841-11</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>70512-841-61</NDCCode><ProprietaryName>Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>70512-872-10</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>81877-512-10</NDCCode><ProprietaryName>Dicloprep-100</ProprietaryName><NonProprietaryName>Diclofenac Sodium, Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>82226-020-10</NDCCode><ProprietaryName>Valcoprep-100</ProprietaryName><NonProprietaryName>Diclofenac Sodium, Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>10695-037-11</NDCCode><NonProprietaryName>Epinephrine</NonProprietaryName></NDC><NDC><NDCCode>12707-037-01</NDCCode><NonProprietaryName>Naloxone Hydrochloride Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>16714-037-10</NDCCode><ProprietaryName>Ephedrine Sulfate</ProprietaryName><NonProprietaryName>Ephedrine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>21695-037-10</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42507-037-10</NDCCode><ProprietaryName>Nasal</ProprietaryName><NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50242-120-47</NDCCode><ProprietaryName>Tnkase</ProprietaryName><NonProprietaryName>Tenecteplase</NonProprietaryName></NDC><NDC><NDCCode>50242-176-01</NDCCode><ProprietaryName>Tnkase</ProprietaryName><NonProprietaryName>Tenecteplase</NonProprietaryName></NDC><NDC><NDCCode>51621-037-01</NDCCode><ProprietaryName>Dr.g Dewrinkle Booster Ample</ProprietaryName><NonProprietaryName>Glycerin</NonProprietaryName></NDC><NDC><NDCCode>52584-037-10</NDCCode><ProprietaryName>Ketalar</ProprietaryName><NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54879-037-25</NDCCode><ProprietaryName>Succinylcholine Chloride</ProprietaryName><NonProprietaryName>Succinylcholine Chloride</NonProprietaryName></NDC><NDC><NDCCode>54879-037-50</NDCCode><ProprietaryName>Succinylcholine Chloride</ProprietaryName><NonProprietaryName>Succinylcholine Chloride</NonProprietaryName></NDC><NDC><NDCCode>55390-037-10</NDCCode><ProprietaryName>Vecuronium Bromide</ProprietaryName><NonProprietaryName>Vecuronium Bromide</NonProprietaryName></NDC><NDC><NDCCode>58159-037-04</NDCCode><NonProprietaryName>Nitisinone</NonProprietaryName></NDC><NDC><NDCCode>60592-037-10</NDCCode><NonProprietaryName>Levamisol Hcl</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",
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      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "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",
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}
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