RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>0268-0970-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL (0268-0970-10) </PackageDescription>
    <NDC11Code>00268-0970-10</NDC11Code>
    <ProductNDC>0268-0970</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Mixed Aspergillus</ProprietaryName>
    <NonProprietaryName>Mixed Aspergillus</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19650101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103753</ApplicationNumber>
    <LabelerName>ALK-Abello, Inc.</LabelerName>
    <SubstanceName>ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS TERREUS</SubstanceName>
    <StrengthNumber>20000; 20000; 20000; 20000</StrengthNumber>
    <StrengthUnit>[PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-05-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19650101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>43063-970-10</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (43063-970-10) </PackageDescription>
    <NDC11Code>43063-0970-10</NDC11Code>
    <ProductNDC>43063-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19861210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071321</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Diazepam tablets, USP are a benzodiazepine derivative. The chemical name of diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is an off-white to yellow crystalline powder, insoluble in water. The structural formula is as follows. C 16H 13ClN 2O             M.W. 284.74. Diazepam tablets, USP are available as 2 mg, 5 mg, or 10 mg tablets for oral administration containing the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&amp;C Yellow No. 10 aluminum lake and FD&amp;C Yellow No. 6); 10 mg only (FD&amp;C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>51407-970-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (51407-970-10) </PackageDescription>
    <NDC11Code>51407-0970-10</NDC11Code>
    <ProductNDC>51407-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140820</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204279</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250304</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates,so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Hydroxyzine hydrochloride, USP has the chemical name of (±)-2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Molecular Formula: C 21H 27ClN 2O 2· 2HCl Molecular Weight:  447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg, or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>54575-970-10</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-970-10)</PackageDescription>
    <NDC11Code>54575-0970-10</NDC11Code>
    <ProductNDC>54575-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tree Of Heaven Pollen</ProprietaryName>
    <NonProprietaryName>Ailanthus Altissima Pollen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19671207</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101376</ApplicationNumber>
    <LabelerName>Allergy Laboratories, Inc.</LabelerName>
    <SubstanceName>AILANTHUS ALTISSIMA POLLEN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established:             Coffee             Cottonseed       Flaxseed             Housefly             Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
  </NDC>
  <NDC>
    <NDCCode>55319-970-10</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (55319-970-10)  / 100 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>55319-0970-10</NDC11Code>
    <ProductNDC>55319-970</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Migraine Relief</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Aspirin, Caffeine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230701</StartMarketingDate>
    <EndMarketingDate>20261231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214039</ApplicationNumber>
    <LabelerName>Family Dollar (FAMILY WELLNESS)</LabelerName>
    <SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
    <StrengthNumber>250; 250; 65</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230701</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>treats migraine.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>60429-970-10</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE, PLASTIC (60429-970-10) </PackageDescription>
    <NDC11Code>60429-0970-10</NDC11Code>
    <ProductNDC>60429-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19860513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070791</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.</IndicationAndUsage>
    <Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19H 21NO  HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula:. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[ b, e]oxepin-11 (6 H)ylidene- N, N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&amp;C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&amp;C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&amp;C Green No. 3. The imprinting ink contains black iron oxide, D&amp;C Yellow No. 10 Aluminum Lake, FD&amp;C Blue No. 1 Aluminum Lake, FD&amp;C Blue No. 2 Aluminum Lake, FD&amp;C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
  </NDC>
  <NDC>
    <NDCCode>61786-970-10</NDCCode>
    <PackageDescription>6 TABLET in 1 BOTTLE (61786-970-10) </PackageDescription>
    <NDC11Code>61786-0970-10</NDC11Code>
    <ProductNDC>61786-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
    <NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076899</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
    <StrengthNumber>800; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68382-970-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (68382-970-10) </PackageDescription>
    <NDC11Code>68382-0970-10</NDC11Code>
    <ProductNDC>68382-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Chlorthalidone</ProprietaryName>
    <NonProprietaryName>Chlorthalidone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207813</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>CHLORTHALIDONE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diuretics such as chlorthalidone tablets, USP are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone tablets, USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone tablets, USP has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
    <Description>Chlorthalidone is an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-chloro-5(1- hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14 H11ClN2 O4 S. Molecular weight: 338.76. Chlorthalidone, USP is white to yellowish-white, crystalline powder that melts at a temperature 216°C to 222°C, with decomposition. It is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in alcohol. Chlorthalidone tablets, USP are available containing either 25 mg or 50 mg of chlorthalidone USP and the following inactive ingredients: colloidal silicon dioxide, corn starch,microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid.Additionally 25 mg tablet contain ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>0069-0970-65</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0069-0970-65)  / 60 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00069-0970-65</NDC11Code>
    <ProductNDC>0069-0970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vibramycin Monohydrate</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19671206</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050006</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>DOXYCYCLINE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19671206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Vibramycin and other antibacterial drugs, Vibramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Vibramycin is an antibacterial drug synthetically derived from oxytetracycline, and is available as Vibramycin Monohydrate (doxycycline monohydrate); Vibramycin Hyclate and Vibra-Tabs (doxycycline hydrochloride hemiethanolate hemihydrate); and Vibramycin Calcium (doxycycline calcium) for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients in the syrup formulation are: apple flavor; butylparaben; calcium chloride; carmine; glycerin; hydrochloric acid; magnesium aluminum silicate; povidone; propylene glycol; propylparaben; raspberry flavor; simethicone emulsion; sodium hydroxide; sodium metabisulfite; sorbitol solution; water. Inert ingredients in the capsule formulations are: hard gelatin capsules (which may contain Blue 1 and other inert ingredients); magnesium stearate; microcrystalline cellulose; sodium lauryl sulfate. Inert ingredients for the oral suspension formulation are: carboxymethylcellulose sodium; Blue 1; methylparaben; microcrystalline cellulose; propylparaben; raspberry flavor; Red 28; simethicone emulsion; sucrose. Inert ingredients for the tablet formulation are: ethylcellulose; hypromellose; magnesium stearate; microcrystalline cellulose; propylene glycol; sodium lauryl sulfate; talc; titanium dioxide; Yellow 6 Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>0363-0970-63</NDCCode>
    <PackageDescription>2 CAN in 1 PACKAGE (0363-0970-63)  / 156 mL in 1 CAN (0363-0970-37) </PackageDescription>
    <NDC11Code>00363-0970-63</NDC11Code>
    <ProductNDC>0363-0970</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Walgreens Spf 30 Hydrating Continuous</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octocrylene,</NonProprietaryName>
    <DosageFormName>AEROSOL, SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191114</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>WALGREEN COMPANY</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>20; 70; 50</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0430-0970-00</NDCCode>
    <PackageDescription>22792 TABLET, DELAYED RELEASE in 1 DRUM (0430-0970-00) </PackageDescription>
    <NDC11Code>00430-0970-00</NDC11Code>
    <ProductNDC>0430-0970</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Risedronate Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <StartMarketingDate>20101201</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE</SubstanceName>
    <StrengthNumber>30.1; 4.9</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-12-05</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-DEC-10</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0536-0970-85</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (0536-0970-85) </PackageDescription>
    <NDC11Code>00536-0970-85</NDC11Code>
    <ProductNDC>0536-0970</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Extra Action Cough</ProprietaryName>
    <NonProprietaryName>Guaifenesin And Dextromethorphan Hydrobromide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110203</StartMarketingDate>
    <EndMarketingDate>20200531</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Rugby Laboratories Inc.</LabelerName>
    <SubstanceName>GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>100; 10</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110203</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0536-0970-97</NDCCode>
    <PackageDescription>118 mL in 1 BOTTLE (0536-0970-97) </PackageDescription>
    <NDC11Code>00536-0970-97</NDC11Code>
    <ProductNDC>0536-0970</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Extra Action Cough</ProprietaryName>
    <NonProprietaryName>Guaifenesin And Dextromethorphan Hydrobromide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110203</StartMarketingDate>
    <EndMarketingDate>20200531</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Rugby Laboratories Inc.</LabelerName>
    <SubstanceName>GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
    <StrengthNumber>100; 10</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-03-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110203</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200330</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>17224-970-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (17224-970-30) </PackageDescription>
    <NDC11Code>17224-0970-30</NDC11Code>
    <ProductNDC>17224-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolpidem Tartrate</ProprietaryName>
    <NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070905</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077903</ApplicationNumber>
    <LabelerName>Calvin Scott &amp; Co., Inc.</LabelerName>
    <SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.</IndicationAndUsage>
    <Description>Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>21130-970-04</NDCCode>
    <PackageDescription>1814 g in 1 POUCH (21130-970-04) </PackageDescription>
    <NDC11Code>21130-0970-04</NDC11Code>
    <ProductNDC>21130-970</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Epsom Salt</ProprietaryName>
    <NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
    <DosageFormName>GRANULE</DosageFormName>
    <RouteName>ORAL; TOPICAL</RouteName>
    <StartMarketingDate>20230201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>Safeway, Inc.</LabelerName>
    <SubstanceName>MAGNESIUM SULFATE, UNSPECIFIED</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for relief of occasional constipation (irregularity). this product generally produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>23155-970-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (23155-970-01) </PackageDescription>
    <NDC11Code>23155-0970-01</NDC11Code>
    <ProductNDC>23155-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Midodrine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Midodrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260325</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076725</ApplicationNumber>
    <LabelerName>Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>MIDODRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260325</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP&gt;200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.</IndicationAndUsage>
    <Description>Name:Midodrine hydrochloride tablets, USP. Dosage Form:2.5 mg, 5 mg and 10 mg tablets for oral administration. Active Ingredient:Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg. Inactive Ingredients:colloidal silicon dioxide, corn starch, FD&amp;C Blue No. 1 Lake (10 mg tablets), FD&amp;C Red No. 40 Lake (5 mg and 10 mg tablets), magnesium stearate, microcrystalline cellulose and talc. Pharmacological Classification:Vasopressor/Antihypotensive. Chemical Names(USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-;. (2) (±)-2-amino- N-(β-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine.</Description>
  </NDC>
  <NDC>
    <NDCCode>24555-0970-3</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (24555-0970-3) </PackageDescription>
    <NDC11Code>24555-0970-03</NDC11Code>
    <ProductNDC>24555-0970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buprenorphine And Naloxone</ProprietaryName>
    <NonProprietaryName>Buprenorphine And Naloxone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>SUBLINGUAL</RouteName>
    <StartMarketingDate>20240106</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201633</ApplicationNumber>
    <LabelerName>Correct Rx Pharmacy Services, Inc.</LabelerName>
    <SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE</SubstanceName>
    <StrengthNumber>8; 2</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2024-03-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240106</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buprenorphine and naloxone sublingual tablet is indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablet should be used as part of a complete treatment plan that includes counseling and psychosocial support.</IndicationAndUsage>
    <Description>Buprenorphine and naloxone sublingual tablet is uncoated, round, biconvex, orange tablet. It contains buprenorphine hydrochloride USP, a partial agonist at the mu-opioid receptor, and naloxone hydrochloride dihydrate USP, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual administration and is available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. Each sublingual tablet also contains lactose monohydrate, mannitol, povidone, anhydrous citric acid, sodium citrate, FD&amp;C Yellow No. 6 color, butylated hydroxyanisole, corn starch, pregelatinized starch, magnesium stearate, acesulfame potassium sweetener and a lemon / lime flavor. Chemically, buprenorphine hydrochloride is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6­-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure: Buprenorphine hydrochloride has the molecular formula C 29H 41NO 4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone hydrochloride dihydrate is 17-Allyl-4, 5α-epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C 19H 21NO 4 HCl  2H 2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is soluble in water, slightly soluble in alcohol and practically insoluble in toluene and ether.</Description>
  </NDC>
  <NDC>
    <NDCCode>37000-970-08</NDCCode>
    <PackageDescription>236 mL in 1 BOTTLE, PLASTIC (37000-970-08) </PackageDescription>
    <NDC11Code>37000-0970-08</NDC11Code>
    <ProductNDC>37000-970</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vicks Severe</ProprietaryName>
    <ProprietaryNameSuffix>Cold And Flu</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Guaifenesin, Phenylephrine Hcl, Dextromethorphan Hbr</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200428</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 10; 200; 5</StrengthNumber>
    <StrengthUnit>mg/15mL; mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200428</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>37000-970-12</NDCCode>
    <PackageDescription>354 mL in 1 BOTTLE, PLASTIC (37000-970-12) </PackageDescription>
    <NDC11Code>37000-0970-12</NDC11Code>
    <ProductNDC>37000-970</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vicks Severe</ProprietaryName>
    <ProprietaryNameSuffix>Cold And Flu</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Guaifenesin, Phenylephrine Hcl, Dextromethorphan Hbr</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200428</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 10; 200; 5</StrengthNumber>
    <StrengthUnit>mg/15mL; mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200428</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>42291-970-60</NDCCode>
    <PackageDescription>60 TABLET, COATED in 1 BOTTLE (42291-970-60) </PackageDescription>
    <NDC11Code>42291-0970-60</NDC11Code>
    <ProductNDC>42291-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zafirlukast</ProprietaryName>
    <NonProprietaryName>Zafirlukast</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230405</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020547</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>ZAFIRLUKAST</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230405</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zafirlukast is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.</IndicationAndUsage>
    <Description>Zafirlukast is a synthetic, selective peptide leukotriene receptor antagonist (LTRA), with the chemical name 4-(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3-ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide. The molecular weight of zafirlukast is 575.7 and the structural formula is. The empirical formula is: C 31H 33N 3O 6S. Zafirlukast, a fine white to pale yellow amorphous powder, is practically insoluble in water. It is slightly soluble in methanol and freely soluble in tetrahydrofuran, dimethylsulfoxide, and acetone. Zafirlukast is supplied as 10 and 20 mg tablets for oral administration. Inactive Ingredients: Film-coated tablets containing croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone, hypromellose, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42543-970-25</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE, PLASTIC (42543-970-25) </PackageDescription>
    <NDC11Code>42543-0970-25</NDC11Code>
    <ProductNDC>42543-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207029</ApplicationNumber>
    <LabelerName>Strides Pharma Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocortisone tablets are indicated in the following conditions.</IndicationAndUsage>
    <Description>Hydrocortisone tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215º C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone tablets, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-970-04</NDCCode>
    <PackageDescription>4 TABLET in 1 BOTTLE, PLASTIC (43063-970-04) </PackageDescription>
    <NDC11Code>43063-0970-04</NDC11Code>
    <ProductNDC>43063-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19861210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071321</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Diazepam tablets, USP are a benzodiazepine derivative. The chemical name of diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is an off-white to yellow crystalline powder, insoluble in water. The structural formula is as follows. C 16H 13ClN 2O             M.W. 284.74. Diazepam tablets, USP are available as 2 mg, 5 mg, or 10 mg tablets for oral administration containing the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&amp;C Yellow No. 10 aluminum lake and FD&amp;C Yellow No. 6); 10 mg only (FD&amp;C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-970-06</NDCCode>
    <PackageDescription>6 TABLET in 1 BOTTLE, PLASTIC (43063-970-06) </PackageDescription>
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    <StartMarketingDate>19861210</StartMarketingDate>
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    <ApplicationNumber>ANDA071321</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
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    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
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    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Diazepam tablets, USP are a benzodiazepine derivative. The chemical name of diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is an off-white to yellow crystalline powder, insoluble in water. The structural formula is as follows. C 16H 13ClN 2O             M.W. 284.74. Diazepam tablets, USP are available as 2 mg, 5 mg, or 10 mg tablets for oral administration containing the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&amp;C Yellow No. 10 aluminum lake and FD&amp;C Yellow No. 6); 10 mg only (FD&amp;C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.</Description>
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  <NDC>
    <NDCCode>43063-970-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (43063-970-15) </PackageDescription>
    <NDC11Code>43063-0970-15</NDC11Code>
    <ProductNDC>43063-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19861210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071321</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Diazepam tablets, USP are a benzodiazepine derivative. The chemical name of diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is an off-white to yellow crystalline powder, insoluble in water. The structural formula is as follows. C 16H 13ClN 2O             M.W. 284.74. Diazepam tablets, USP are available as 2 mg, 5 mg, or 10 mg tablets for oral administration containing the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&amp;C Yellow No. 10 aluminum lake and FD&amp;C Yellow No. 6); 10 mg only (FD&amp;C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-970-21</NDCCode>
    <PackageDescription>21 TABLET in 1 BOTTLE, PLASTIC (43063-970-21) </PackageDescription>
    <NDC11Code>43063-0970-21</NDC11Code>
    <ProductNDC>43063-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19861210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071321</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190507</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Diazepam tablets, USP are a benzodiazepine derivative. The chemical name of diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is an off-white to yellow crystalline powder, insoluble in water. The structural formula is as follows. C 16H 13ClN 2O             M.W. 284.74. Diazepam tablets, USP are available as 2 mg, 5 mg, or 10 mg tablets for oral administration containing the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&amp;C Yellow No. 10 aluminum lake and FD&amp;C Yellow No. 6); 10 mg only (FD&amp;C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-970-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43063-970-30) </PackageDescription>
    <NDC11Code>43063-0970-30</NDC11Code>
    <ProductNDC>43063-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19861210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071321</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Diazepam tablets, USP are a benzodiazepine derivative. The chemical name of diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is an off-white to yellow crystalline powder, insoluble in water. The structural formula is as follows. C 16H 13ClN 2O             M.W. 284.74. Diazepam tablets, USP are available as 2 mg, 5 mg, or 10 mg tablets for oral administration containing the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&amp;C Yellow No. 10 aluminum lake and FD&amp;C Yellow No. 6); 10 mg only (FD&amp;C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43063-970-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (43063-970-60) </PackageDescription>
    <NDC11Code>43063-0970-60</NDC11Code>
    <ProductNDC>43063-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19861210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071321</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Diazepam tablets, USP are a benzodiazepine derivative. The chemical name of diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is an off-white to yellow crystalline powder, insoluble in water. The structural formula is as follows. C 16H 13ClN 2O             M.W. 284.74. Diazepam tablets, USP are available as 2 mg, 5 mg, or 10 mg tablets for oral administration containing the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&amp;C Yellow No. 10 aluminum lake and FD&amp;C Yellow No. 6); 10 mg only (FD&amp;C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-970-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (43353-970-30)</PackageDescription>
    <NDC11Code>43353-0970-30</NDC11Code>
    <ProductNDC>43353-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071018</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077397</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-29</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).</IndicationAndUsage>
    <Description>Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&amp;C Yellow # 10 Aluminum Lake, and FD&amp;C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400,  FD&amp;C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-970-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (43598-970-05) </PackageDescription>
    <NDC11Code>43598-0970-05</NDC11Code>
    <ProductNDC>43598-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aripiprazole</ProprietaryName>
    <NonProprietaryName>Aripiprazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206383</ApplicationNumber>
    <LabelerName>Dr.Reddy�s Laboratories Inc</LabelerName>
    <SubstanceName>ARIPIPRAZOLE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia, 2 Irritability Associated with Autistic Disorder, 3 Treatment of Tourette’s Disorder.</IndicationAndUsage>
    <Description>Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets. Aripiprazole USP is 7-[4-[4-(2,3-dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C 23H 27Cl 2N 3O 2and its molecular weight is 448.39. The chemical structure is:. Aripiprazole Tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone. Colorants include ferric oxide (yellow or red) and FD&amp;C Blue No. 2 Aluminum Lake. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-970-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (43598-970-30) </PackageDescription>
    <NDC11Code>43598-0970-30</NDC11Code>
    <ProductNDC>43598-970</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aripiprazole</ProprietaryName>
    <NonProprietaryName>Aripiprazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200316</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206383</ApplicationNumber>
    <LabelerName>Dr.Reddy�s Laboratories Inc</LabelerName>
    <SubstanceName>ARIPIPRAZOLE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200316</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of: 1 Schizophrenia, 2 Irritability Associated with Autistic Disorder, 3 Treatment of Tourette’s Disorder.</IndicationAndUsage>
    <Description>Aripiprazole is an atypical antipsychotic drug that is available as aripiprazole tablets. Aripiprazole USP is 7-[4-[4-(2,3-dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C 23H 27Cl 2N 3O 2and its molecular weight is 448.39. The chemical structure is:. Aripiprazole Tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone. Colorants include ferric oxide (yellow or red) and FD&amp;C Blue No. 2 Aluminum Lake. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
</NDCList>