RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "55045-2386-6",
      "PackageDescription": "50 TABLET in 1 BOTTLE, PLASTIC (55045-2386-6)",
      "NDC11Code": "55045-2386-06",
      "ProductNDC": "55045-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040143",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
      "StrengthNumber": "10; 650",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
    },
    {
      "NDCCode": "55045-2386-7",
      "PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (55045-2386-7)",
      "NDC11Code": "55045-2386-07",
      "ProductNDC": "55045-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040143",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
      "StrengthNumber": "10; 650",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
    },
    {
      "NDCCode": "55045-2386-8",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (55045-2386-8)",
      "NDC11Code": "55045-2386-08",
      "ProductNDC": "55045-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040143",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
      "StrengthNumber": "10; 650",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
    },
    {
      "NDCCode": "55045-1173-0",
      "PackageDescription": "6 TABLET in 1 BOTTLE (55045-1173-0)",
      "NDC11Code": "55045-1173-00",
      "ProductNDC": "55045-1173",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091123",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078558",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
      "Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid.  Ibuprofen is a white powder with a melting point of 74-77° 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, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
    },
    {
      "NDCCode": "55045-3197-6",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55045-3197-6)",
      "NDC11Code": "55045-3197-06",
      "ProductNDC": "55045-3197",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hydrochloride",
      "NonProprietaryName": "Bupropion Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "OCCLUSIVE DRESSING TECHNIQUE",
      "StartMarketingDate": "20090702",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079095",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-01-10",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (SR) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
      "Description": "Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1- dimethylethyl)amino]-1 -propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100 mg, 150 mg, and 200 mg white to off-white, film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients:  hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate, and diluted hydrochloric acid. The film coating contains lactose monohydrate, hydroxypropyl cellulose, titanium dioxide, and polyethylene glycol."
    },
    {
      "NDCCode": "68071-2386-6",
      "PackageDescription": "60 TABLET in 1 BOTTLE (68071-2386-6) ",
      "NDC11Code": "68071-2386-06",
      "ProductNDC": "68071-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203769",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210413",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
      "Description": "Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white crystalline compound with a molecular formula of C 4H 11N 5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pK a of metformin is 12.4. The p H of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains hypromellose, polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide."
    },
    {
      "NDCCode": "71335-2386-6",
      "PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (71335-2386-6) ",
      "NDC11Code": "71335-2386-06",
      "ProductNDC": "71335-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prochlorperazine Maleate",
      "NonProprietaryName": "Prochlorperazine Maleate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230913",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217478",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "PROCHLORPERAZINE MALEATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-05-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240529",
      "SamplePackage": "N",
      "IndicationAndUsage": "For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine maleate tablets as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine maleate tablets have not been shown effective in the management of behavioral complications in patients with mental retardation.",
      "Description": "Prochlorperazine is a phenothiazine derivative, present in prochlorperazine maleate tablets, USP as the maleate. Its chemical name is 2-chloro-10-[3-(4- methyl-1-piperazinyl)propyl]-10H-phenothiazine (Z)-2-butenedioate (1:2). Prochlorperazine maleate, USP. Prochlorperazine maleate, USP is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate, USP, has the molecular formula C 20H 24ClN 3S2C 4H 4O 4, and the molecular weight is 606.09 g/mol. Prochlorperazine maleate, USP, is a white or pale-yellow crystalline powder. It is slightly soluble in warm chloroform and practically insoluble in water and alcohol. Each film-coated tablet for oral administration contains prochlorperazine maleate, USP equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each film-coated tablet contains the following inactive ingredients consist of colloidal silicon dioxide, corn starch, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6, FD&C blue no. 2, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, and titanium dioxide."
    },
    {
      "NDCCode": "71335-2386-8",
      "PackageDescription": "6 TABLET, FILM COATED in 1 BOTTLE (71335-2386-8) ",
      "NDC11Code": "71335-2386-08",
      "ProductNDC": "71335-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prochlorperazine Maleate",
      "NonProprietaryName": "Prochlorperazine Maleate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230913",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217478",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "PROCHLORPERAZINE MALEATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-05-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240529",
      "SamplePackage": "N",
      "IndicationAndUsage": "For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine maleate tablets as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine maleate tablets have not been shown effective in the management of behavioral complications in patients with mental retardation.",
      "Description": "Prochlorperazine is a phenothiazine derivative, present in prochlorperazine maleate tablets, USP as the maleate. Its chemical name is 2-chloro-10-[3-(4- methyl-1-piperazinyl)propyl]-10H-phenothiazine (Z)-2-butenedioate (1:2). Prochlorperazine maleate, USP. Prochlorperazine maleate, USP is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate, USP, has the molecular formula C 20H 24ClN 3S2C 4H 4O 4, and the molecular weight is 606.09 g/mol. Prochlorperazine maleate, USP, is a white or pale-yellow crystalline powder. It is slightly soluble in warm chloroform and practically insoluble in water and alcohol. Each film-coated tablet for oral administration contains prochlorperazine maleate, USP equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each film-coated tablet contains the following inactive ingredients consist of colloidal silicon dioxide, corn starch, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6, FD&C blue no. 2, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, and titanium dioxide."
    },
    {
      "NDCCode": "0781-2386-01",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2386-01) ",
      "NDC11Code": "00781-2386-01",
      "ProductNDC": "0781-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylphenidate",
      "NonProprietaryName": "Methylphenidate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151124",
      "MarketingCategoryName": "NDA AUTHORIZED GENERIC",
      "ApplicationNumber": "NDA021284",
      "LabelerName": "Sandoz Inc",
      "SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-10-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250303",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)]. Limitations of Use. The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
      "Description": "Methylphenidate hydrochloride extended-release capsules are CNS stimulant. Methylphenidate hydrochloride extended-release capsules is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in methylphenidate hydrochloride extended-release capsules is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, black iron oxide (10 and 40 mg capsules only), gelatin, methacrylic acid copolymer, polyethylene glycol, red iron oxide (10 and 40 mg capsules only), sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide (10, 30, and 40 mg capsules only)."
    },
    {
      "NDCCode": "55714-2386-0",
      "PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-2386-0) ",
      "NDC11Code": "55714-2386-00",
      "ProductNDC": "55714-2386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Appetite - Craving Control",
      "NonProprietaryName": "Anacardium Orientale, Antimon.crud., Arg. Nit., Berber. Vulg., Bryonia, Chelidonium Majus, Digitalis, Graphites, Humulus,iris Versicolor, Kali Carb., Lycopodium, Nat. Carb.,nat. Sulphuricum, Nux Vom., Pulsatilla, Rhus. Toxicodendron, Scutellaria Lateriflora, Sepia,stramonium, Chamomilla, Passiflora, Valeriana.",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181029",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Newton Laboratories, Inc.",
      "SubstanceName": "SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN",
      "StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 6; 6",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181029",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55714-2386-1",
      "PackageDescription": "30 mL in 1 BOTTLE, GLASS (55714-2386-1) ",
      "NDC11Code": "55714-2386-01",
      "ProductNDC": "55714-2386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Appetite - Craving Control",
      "NonProprietaryName": "Anacardium Orientale, Antimon.crud., Arg. Nit., Berber. Vulg., Bryonia, Chelidonium Majus, Digitalis, Graphites, Humulus,iris Versicolor, Kali Carb., Lycopodium, Nat. Carb.,nat. Sulphuricum, Nux Vom., Pulsatilla, Rhus. Toxicodendron, Scutellaria Lateriflora, Sepia,stramonium, Chamomilla, Passiflora, Valeriana.",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181029",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Newton Laboratories, Inc.",
      "SubstanceName": "LYCOPODIUM CLAVATUM SPORE; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN",
      "StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 6; 6",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-02-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181029",
      "SamplePackage": "N",
      "IndicationAndUsage": "Formulated for symptoms such as overeating, cravings, fatigue, diminished appetite and emotional discomfort."
    },
    {
      "NDCCode": "55714-2386-2",
      "PackageDescription": "50 mL in 1 BOTTLE, GLASS (55714-2386-2) ",
      "NDC11Code": "55714-2386-02",
      "ProductNDC": "55714-2386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Appetite - Craving Control",
      "NonProprietaryName": "Anacardium Orientale, Antimon.crud., Arg. Nit., Berber. Vulg., Bryonia, Chelidonium Majus, Digitalis, Graphites, Humulus,iris Versicolor, Kali Carb., Lycopodium, Nat. Carb.,nat. Sulphuricum, Nux Vom., Pulsatilla, Rhus. Toxicodendron, Scutellaria Lateriflora, Sepia,stramonium, Chamomilla, Passiflora, Valeriana.",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181029",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Newton Laboratories, Inc.",
      "SubstanceName": "SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN",
      "StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 6; 6",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181029",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63629-2386-1",
      "PackageDescription": "1000 CAPSULE in 1 BOTTLE (63629-2386-1) ",
      "NDC11Code": "63629-2386-01",
      "ProductNDC": "63629-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phentermine Hydrochloride",
      "NonProprietaryName": "Phentermine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170124",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205017",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "PHENTERMINE HYDROCHLORIDE",
      "StrengthNumber": "37.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-02-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170124",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
      "Description": "Phentermine hydrochloride USP is a sympathomimetic amine anorectic. It has the chemical name of α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15NHCl                                                                            M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule or tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP 37.5 mg contain the inactive ingredients Colloidal Silicon Dioxide, Corn Starch, FD&C Blue # 1, FD&C Red # 3, FD&C Yellow # 6, Gelatin, Lactose Monohydrate, Magnesium Stearate, and Titanium Dioxide. The ingredients in the black imprinting ink are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide. Phentermine hydrochloride tablets, USP 37.5 mg contain the inactive ingredients Colloidal Silicon Dioxide, Corn Starch, FD&C Blue # 1, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch (botanical source: maize), Sugar Spheres, and Stearic Acid."
    },
    {
      "NDCCode": "68071-2386-1",
      "PackageDescription": "180 TABLET in 1 BOTTLE (68071-2386-1) ",
      "NDC11Code": "68071-2386-01",
      "ProductNDC": "68071-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203769",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210413",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
      "Description": "Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white crystalline compound with a molecular formula of C 4H 11N 5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pK a of metformin is 12.4. The p H of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains hypromellose, polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide."
    },
    {
      "NDCCode": "68071-2386-2",
      "PackageDescription": "120 TABLET in 1 BOTTLE (68071-2386-2) ",
      "NDC11Code": "68071-2386-02",
      "ProductNDC": "68071-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203769",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210413",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
      "Description": "Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white crystalline compound with a molecular formula of C 4H 11N 5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pK a of metformin is 12.4. The p H of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains hypromellose, polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide."
    },
    {
      "NDCCode": "68071-2386-3",
      "PackageDescription": "30 TABLET in 1 BOTTLE (68071-2386-3) ",
      "NDC11Code": "68071-2386-03",
      "ProductNDC": "68071-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203769",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210413",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
      "Description": "Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white crystalline compound with a molecular formula of C 4H 11N 5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pK a of metformin is 12.4. The p H of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains hypromellose, polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide."
    },
    {
      "NDCCode": "68071-2386-9",
      "PackageDescription": "90 TABLET in 1 BOTTLE (68071-2386-9) ",
      "NDC11Code": "68071-2386-09",
      "ProductNDC": "68071-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203769",
      "LabelerName": "NuCare Pharmaceuticals,Inc.",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210413",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
      "Description": "Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white crystalline compound with a molecular formula of C 4H 11N 5  HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pK a of metformin is 12.4. The p H of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains hypromellose, polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide."
    },
    {
      "NDCCode": "55045-1194-2",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (55045-1194-2)  > 10 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "55045-1194-02",
      "ProductNDC": "55045-1194",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Neomycin And Polymyxin B Sulfates And Gramicidin",
      "NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Gramicidin",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19960131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA064047",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN",
      "StrengthNumber": "1.75; 10000; .025",
      "StrengthUnit": "mg/mL; [USP'U]/mL; mg/mL",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.",
      "Description": "Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP is a sterile antimicrobial solution for ophthalmic use. EACH mL CONTAINS: ACTIVES: Neomycin Sulfate, (equivalent to 1.75 mg neomycin base), Polymyxin B Sulfate equal to 10,000 Polymyxin B units, Gramicidin, 0.025 mg; INACTIVES: Sodium Chloride, Alcohol (0.5%), Poloxamer 188, Propylene Glycol, Purified Water. Hydrochloric Acid and/ or Ammonium Hydroxide may be added to adjust pH (4.7- 6.0). PRESERVATIVE ADDED: Thimerosal 0.001%. Neomycin Sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis. The structural formulae are. Polymyxin B Sulfate is the sulfate salt of polymyxin Bl and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are. Gramicidin (also called gramicidin D) is a mixture of three pairs of antibacterial substances (Gramicidin A, B and C) produced by the growth of Bacillusbrevis Dubos (Fam. Bacillaceae). It has a potency of not less than 900 mcg of standard gramicidin per mg. The structural formulae are."
    },
    {
      "NDCCode": "55045-1259-9",
      "PackageDescription": "21 TABLET in 1 BOTTLE, PLASTIC (55045-1259-9)",
      "NDC11Code": "55045-1259-09",
      "ProductNDC": "55045-1259",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylprednisolone",
      "NonProprietaryName": "Methylprednisolone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19981222",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040183",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "METHYLPREDNISOLONE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "MethylPREDNISolone Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital adrenal hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis, 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisSynovitis of osteoarthritisAcute nonspecific tenosynovitisPsoriatic arthritisEpicondylitisAcute gouty arthritisPost-traumatic osteoarthritis, 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditisSystemic dermatomyositis (polymyositis), 4 Dermatologic DiseasesBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Severe seborrheic dermatitisExfoliative dermatitisMycosis fungoidesPemphigusSevere psoriasis, 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisSerum sicknessContact dermatitisDrug hypersensitivity reactionsBronchial asthmaAtopic dermatitis, 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersAnterior segment inflammationSympathetic ophthalmiaKeratitisOptic neuritisIritis and iridocyclitisHerpes zoster ophthalmicusDiffuse posterior uveitis and choroiditisAllergic conjunctivitisChorioretinitis, 7 Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitisBerylliosis, 8 Hematologic DisordersIdiopathic thrombocytopenia purpura in adultsAcquired (autoimmune) hemolytic anemiaCongenital (erythroid) hypoplastic anemiaSecondary thrombocytopenia in adultsErythroblastopenia (RBC anemia), 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus., 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 Nervous SystemAcute exacerbations of multiple sclerosis, 13 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Trichinosis with neurologic or myocardial involvement.",
      "Description": "Methylprednisolone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-, and the molecular weight is 374.48. The structural formula is represented below. Each MethylPREDNISolone Tablet for oral administration contains 4 mg methylprednisolone."
    },
    {
      "NDCCode": "55045-1266-8",
      "PackageDescription": "118 mL in 1 BOTTLE (55045-1266-8)",
      "NDC11Code": "55045-1266-08",
      "ProductNDC": "55045-1266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Promethazine Vc With Codeine",
      "NonProprietaryName": "Codeine Phosphate, Promethazine Hydrochloride, And Phenylephrine Hydrochloride",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "20061207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040660",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "10; 6.5; 5",
      "StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
      "Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Promethazine HCl, phenylephrine HCl and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.",
      "Description": "Each 5 mL (one teaspoonful), for oral administration contains: Codeine phosphate 10 mg; promethazine hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, D&C Red #33, FD&C Yellow #6, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate, strawberry flavor and sucrose. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C18H21NO3  H3PO4  ½H2O and the following structural formula. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S  HCI and the following structural formula. Phenylephrine hydrochloride is a sympathomimetic amine salt which is chemically indicated as (-)-m-Hydroxy-α-[(methyl-amino)-methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. It has a molecular weight of 203.67, a molecular formula of C9H13NO2  HCI and the following structural formula."
    },
    {
      "NDCCode": "55045-1350-9",
      "PackageDescription": "1 TUBE in 1 CARTON (55045-1350-9)  > 3.5 g in 1 TUBE",
      "NDC11Code": "55045-1350-09",
      "ProductNDC": "55045-1350",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Erythromycin",
      "NonProprietaryName": "Erythromycin",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19960718",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA064030",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "ERYTHROMYCIN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin. For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis. The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N.gonorrhoeae is not established. For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.",
      "Description": "Erythromycin Ophthalmic Ointment belongs to the macrolide group of antibiotics. It is basic and readily forms a salt when combined with an acid. The base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin ((3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethyl-amino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione)) is an antibiotic produced from a strain of Streptomyces erythraeus. It has the following structural formula:. Each gram contains Erythromycin USP 5 mg in a sterile ophthalmic base of mineral oil and white petrolatum."
    },
    {
      "NDCCode": "55045-1643-9",
      "PackageDescription": "118 mL in 1 BOTTLE (55045-1643-9)",
      "NDC11Code": "55045-1643-09",
      "ProductNDC": "55045-1643",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Promethazine Hydrochloride",
      "NonProprietaryName": "Promethazine Hydrochloride",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060426",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040643",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
      "StrengthNumber": "6.25",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Promethazine is useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
      "Description": "Each 5 mL of Promethazine Plain Syrup contains 6.25 mg of promethazine HCl. Alcohol 7%. The inactive ingredients present are: Apple-watermelon flavor, ascorbic acid, citric acid, D&C red #33, D&C yellow #10, FD&C blue #1, FD&C yellow #6, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sucrose. Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is 320.88. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
    },
    {
      "NDCCode": "55045-1755-5",
      "PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (55045-1755-5)",
      "NDC11Code": "55045-1755-05",
      "ProductNDC": "55045-1755",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dexamethasone Sodium Phosphate",
      "NonProprietaryName": "Dexamethasone Sodium Phosphate",
      "DosageFormName": "SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20040701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088771",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "For the treatment of the following conditions. Ophthalmic: Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctuate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical or thermal burns, or penetration of foreign bodies. Otic: Steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.",
      "Description": "Dexamethasone sodium phosphate ophthalmic solution is a clear, colorless to pale yellow topical steroid solution for ophthalmic or otic administration. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic. Dexamethasone is a synthetic analog of naturally occurring glucocorticoids (hydrocortisone and cortisone). Dexamethasone sodium phosphate is a water soluble, inorganic ester of dexamethasone. It is approximately three thousand times more soluble in water at 25°C than hydrocortisone. Dexamethasone sodium phosphate is 9-fluoro-11 β, 17-dihydroxy-16 -methyl-21-(phosphonooxy)pregna-1,4-diene-3, 20-dione disodium salt and has the following structural formula. Each mL contains: Active: dexamethasone sodium phosphate equivalent to 1mg (0.1%) dexamethasone phosphate. Preservative: benzalkonium chloride 0.01%. Inactives: monobasic sodium phosphate, sodium chloride, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate and/or dibasic sodium phosphate to adjust pH (6.6 to 7.8) and water for injection."
    },
    {
      "NDCCode": "55045-3243-5",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (55045-3243-5)",
      "NDC11Code": "55045-3243-05",
      "ProductNDC": "55045-3243",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Depo-medrol",
      "NonProprietaryName": "Methylprednisolone Acetate",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE",
      "StartMarketingDate": "19590528",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA011757",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "METHYLPREDNISOLONE ACETATE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows. Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal Diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy), ulcerative colitis. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases: For palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis. Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases: Berylliosis, symptomatic sarcoidosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
      "Description": "DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in three strengths: 20 mg/mL; 40 mg/mL; 80 mg/mL. Each mL of these preparations contains. Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range; e.g., 3.5 to 7.0. The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11ß)-and the molecular weight is 416.51. The structural formula is represented below. DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water."
    },
    {
      "NDCCode": "55045-3683-1",
      "PackageDescription": "25 VIAL in 1 PACKAGE (55045-3683-1)  > 1 mL in 1 VIAL",
      "NDC11Code": "55045-3683-01",
      "ProductNDC": "55045-3683",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diphenhydramine Hydrochloride",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19721127",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA080817",
      "LabelerName": "Dispensing Solutions, Inc.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Diphenhydramine  Hydrochloride Injection is effective in adults and pediatric patients,  other than premature infants and neonates, for the following conditions  when the oral form is impractical.",
      "Description": "Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride 50 mg and benzethonium chloride 100 mcg in Water for Injection. pH 4.0-6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment. The chemical name of diphenhydramine hydrochloride is 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. The structural formula is as follows. C17H21NO  HCl MW 291.82. Diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol."
    },
    {
      "NDCCode": "36987-2386-1",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-2386-1)",
      "NDC11Code": "36987-2386-01",
      "ProductNDC": "36987-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Italian Rye Grass",
      "NonProprietaryName": "Italian Rye Grass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "LOLIUM PERENNE SSP. MULTIFLORUM POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-2386-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2386-2)",
      "NDC11Code": "36987-2386-02",
      "ProductNDC": "36987-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Italian Rye Grass",
      "NonProprietaryName": "Italian Rye Grass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "LOLIUM PERENNE SSP. MULTIFLORUM POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-2386-3",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-2386-3)",
      "NDC11Code": "36987-2386-03",
      "ProductNDC": "36987-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Italian Rye Grass",
      "NonProprietaryName": "Italian Rye Grass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "LOLIUM PERENNE SSP. MULTIFLORUM POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-2386-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-2386-4)",
      "NDC11Code": "36987-2386-04",
      "ProductNDC": "36987-2386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Italian Rye Grass",
      "NonProprietaryName": "Italian Rye Grass",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "LOLIUM PERENNE SSP. MULTIFLORUM POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "37662-2386-1",
      "PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-2386-1) ",
      "NDC11Code": "37662-2386-01",
      "ProductNDC": "37662-2386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Physostigma Venenosum",
      "NonProprietaryName": "Physostigma Venenosum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230117",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "PHYSOSTIGMA VENENOSUM SEED",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_M]/1",
      "Status": "Active",
      "LastUpdate": "2023-01-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230117",
      "SamplePackage": "N"
    }
  ]
}
                    

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