RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>82868-107-35</NDCCode>
    <PackageDescription>35 TABLET in 1 BOTTLE, PLASTIC (82868-107-35) </PackageDescription>
    <NDC11Code>82868-0107-35</NDC11Code>
    <ProductNDC>82868-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acyclovir</ProprietaryName>
    <NonProprietaryName>Acyclovir</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260429</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204314</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>ACYCLOVIR</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Herpes Zoster Infections:Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes:Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox:Acyclovir tablets are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
    <Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations for oral administration. Acyclovir is a white or almost white, crystalline powder with the molecular formula C 8H 11N 5O 3and a molecular weight of 225.20. It is soluble in diluted hydrochloric acid; slightly soluble in water and insoluble in alcohol. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]- 6H-purin-6-one; it has the following structural formula:. Each acyclovir tablet intended for oral administration contains 400 mg and 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>82868-107-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (82868-107-30) </PackageDescription>
    <NDC11Code>82868-0107-30</NDC11Code>
    <ProductNDC>82868-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acyclovir</ProprietaryName>
    <NonProprietaryName>Acyclovir</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260429</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204314</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>ACYCLOVIR</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260819</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Herpes Zoster Infections:Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes:Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox:Acyclovir tablets are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
    <Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations for oral administration. Acyclovir is a white or almost white, crystalline powder with the molecular formula C 8H 11N 5O 3and a molecular weight of 225.20. It is soluble in diluted hydrochloric acid; slightly soluble in water and insoluble in alcohol. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]- 6H-purin-6-one; it has the following structural formula:. Each acyclovir tablet intended for oral administration contains 400 mg and 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>21922-107-13</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (21922-107-13)  / 35.44 g in 1 TUBE</PackageDescription>
    <NDC11Code>21922-0107-13</NDC11Code>
    <ProductNDC>21922-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine</ProprietaryName>
    <NonProprietaryName>Lidicaine</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260620</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205318</ApplicationNumber>
    <LabelerName>Encube Ethicals, Inc.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.</IndicationAndUsage>
    <Description>Lidocaine ointment USP, 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGE for specific uses. Lidocaine ointment USP, 5% contains lidocaine, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula. Composition of lidocaine ointment USP, 5%: acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, (lidocaine) 5% in a water miscible ointment vehicle containing polyethylene glycol 300 and polyethylene glycol 1450.</Description>
  </NDC>
  <NDC>
    <NDCCode>58159-107-01</NDCCode>
    <PackageDescription>35 kg in 1 DRUM (58159-107-01) </PackageDescription>
    <NDC11Code>58159-0107-01</NDC11Code>
    <ProductNDC>58159-107</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Tetracaine</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20241021</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>TETRACAINE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-10-31</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>21-OCT-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>69879-107-35</NDCCode>
    <PackageDescription>35 mL in 1 TUBE (69879-107-35) </PackageDescription>
    <NDC11Code>69879-0107-35</NDC11Code>
    <ProductNDC>69879-107</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cover-expert Sunscreen Broad Spectrum Spf 15 No.7 Vanilla Beige</ProprietaryName>
    <NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150731</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Luxe Art Beaute SAS</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>51; 28</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84165-006-35</NDCCode>
    <PackageDescription>35 BAG in 1 BOX (84165-006-35)  / 1 KIT in 1 BAG *  21 g in 1 BAG (84165-002-01)  *  12 g in 1 BAG (84165-005-01)  *  9 g in 1 BAG (84165-107-01) </PackageDescription>
    <NDC11Code>84165-0006-35</NDC11Code>
    <ProductNDC>84165-006</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Pain Relief Gel-patch</ProprietaryName>
    <NonProprietaryName>Lidocaine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250414</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Guangzhou Zhupuyou E-commerce Co., Ltd</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250414</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shouldcrs,elbows.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84165-107-35</NDCCode>
    <PackageDescription>35 BAG in 1 BOX (84165-107-35)  / 9 g in 1 BAG (84165-107-01) </PackageDescription>
    <NDC11Code>84165-0107-35</NDC11Code>
    <ProductNDC>84165-107</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Pain Relief Gel-patch</ProprietaryName>
    <NonProprietaryName>Lidocaine</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250228</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Guangzhou Zhupuyou E-commerce Co., Ltd</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>.04</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85537-107-05</NDCCode>
    <PackageDescription>35 mL in 1 BOTTLE, SPRAY (85537-107-05) </PackageDescription>
    <NDC11Code>85537-0107-05</NDC11Code>
    <ProductNDC>85537-107</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Wish Hand Sanitizer Dragonfruit Jasmine</ProprietaryName>
    <NonProprietaryName>Alcohol Hand Sanitizer</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250424</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>PT SUPER HOME PRODUCT INDONESIA</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>82868-052-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (82868-052-30) </PackageDescription>
    <NDC11Code>82868-0052-30</NDC11Code>
    <ProductNDC>82868-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202075</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.1), reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products):. : 1  Have not been tolerated, or are not expected to be tolerated, (1), 2  Have not provided adequate analgesia, or are not expected to provide adequate analgesia (1).</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets USP, for oral use, are an opioid agonist. The chemical name for tramadolhydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients are magnesium stearate, microcrystalline cellulose, milled lactose monohydrate,Opadry White 13B58802, Pregelatinized Starch, sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>82868-078-30</NDCCode>
    <PackageDescription>30 TABLET, COATED in 1 BOTTLE, PLASTIC (82868-078-30) </PackageDescription>
    <NDC11Code>82868-0078-30</NDC11Code>
    <ProductNDC>82868-078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolpidem Tartrate</ProprietaryName>
    <NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077322</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</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>2025-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies ( 14)]. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
    <Description>Zolpidem tartrate is 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 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 contains either 5 mg or 10 mg zolpidem tartrate with the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, hypromellose, hydroxypropyl cellulose, polyethylene glycol, talc, titanium dioxide, carnauba wax; the 10-mg tablet also contains ferric oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>82868-110-30</NDCCode>
    <PackageDescription>30 TABLET, COATED in 1 BOTTLE, PLASTIC (82868-110-30) </PackageDescription>
    <NDC11Code>82868-0110-30</NDC11Code>
    <ProductNDC>82868-110</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260625</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208708</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol Hydrochloride Tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)] reserve opioid analgesics, including tramadol hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .</IndicationAndUsage>
    <Description>Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline powder. It is readily soluble in water and ethanol and has a pKa of 9.41. Then-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets, USP 25 mg, 50 mg, 75 mg and 100 mg contain 25 mg, 50 mg, 75 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>23155-216-31</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, GLASS (23155-216-31) </PackageDescription>
    <NDC11Code>23155-0216-31</NDC11Code>
    <ProductNDC>23155-216</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cidofovir Dihydrate</ProprietaryName>
    <NonProprietaryName>Cidofovir Dihydrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202501</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CIDOFOVIR</SubstanceName>
    <StrengthNumber>375</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-10-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cidofovir injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS. DESCRIPTION OF CLINICAL TRIALS. Three phase II/III controlled trials of cidofovir injection have been conducted in HIV-infected patients with CMV retinitis. Delayed Versus Immediate Therapy (Study 105). In stage 1 of this open-label trial, conducted by the Studies of the Ocular Complications of AIDS (SOCA) Clinical Research Group, 29 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 3 mg/kg every other week) or to have cidofovir injection delayed until progression of CMV retinitis13. In stage 2 of this trial, an additional 35 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 5 mg/kg every other week), immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 3 mg/kg every other week), or to have cidofovir injection delayed until progression of CMV retinitis. Of the 64 patients in this study, 12 were randomized to 5 mg/kg maintenance therapy, 26 to 3 mg/kg maintenance therapy, and 26 to delayed therapy. Of the 12 patients enrolled in the 5 mg/kg maintenance group, 5 patients progressed, 5 patients discontinued therapy and 2 patients had no progression at study completion. Based on masked readings of retinal photographs, the median [95% confidence interval (CI)] time to retinitis progression was not reached (25, not reached) for the 5 mg/kg maintenance group. Median (95% CI) time to the alternative endpoint of retinitis progression or study drug discontinuation was 44 days (24, 207) for the 5 mg/kg maintenance group. Patients receiving 5 mg/kg maintenance had delayed time to retinitis progression compared to patients receiving 3 mg/kg maintenance or deferred therapy. Delayed Versus Immediate Therapy (Study 106). In an open-label trial, 48 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 5 mg/kg every other week), or to have cidofovir injection delayed until progression of CMV retinitis14. Patient baseline characteristics and disposition are shown in Table 3. Of 25 and 23 patients in the immediate and delayed groups respectively, 23 and 21 were evaluable for retinitis progression as determined by retinal photography. Based on masked readings of retinal photographs, the median [95% confidence interval (CI)] times to retinitis progression were 120 days (40, 134) and 22 days (10, 27) for the immediate and delayed therapy groups, respectively. This difference was statistically significant. However, because of the limited number of patients remaining on treatment over time (3 of 25 patients received cidofovir injection for 120 days or longer), the median time to progression for the immediate therapy group was difficult to precisely estimate. Median (95% CI) times to the alternative endpoint of retinitis progression or study drug discontinuation (including adverse events, withdrawn consent, and systemic CMV disease) were 52 days (37, 85) and 22 days (13, 27) for the immediate and delayed therapy groups, respectively. This difference was statistically significant. Time to progression estimates from this study may not be directly comparable to estimates reported for other therapies. Dose-response study of cidofovir injection (Study 107). In an open-label trial, 100 patients with relapsing CMV retinitis were randomized to receive 5 mg/kg once a week for 2 weeks and then either 5 mg/kg (n = 49) or 3 mg/kg (n   = 51) every other week. Enrolled patients had been diagnosed with CMV retinitis an average of 390 days prior to randomization and had received a median of 3.8 prior courses of systemic CMV therapy. Eighty four of the 100 patients were considered evaluable for progression by serial retinal photographs (43 randomized to 5 mg/kg and 41 randomized to 3 mg/kg). Twenty-six and 21 patients discontinued therapy due to either an adverse event, intercurrent illness, excluded medication, or withdrawn consent in the 5 mg/kg and 3 mg/kg groups, respectively. Thirty-eight of the 100 randomized patients had progressed according to masked assessment of serial retinal photographs (13 randomized to 5 mg/kg and 25 randomized to 3 mg/kg). Using retinal photographs, the median (95% CI) times to retinitis progression for the 5 mg/kg and 3 mg/kg groups were 115 days (70, not reached) and 49 days (35, 52), respectively. This difference was statistically significant. Similar to Study 106, the median time to retinitis progression for the 5 mg/kg group was difficult to precisely estimate due to the limited number of patients remaining on treatment over time (4 of the 49 patients in the 5 mg/kg group were treated for 115 days or longer). Median (95% CI) times to the alternative endpoint of retinitis progression or study drug discontinuation were 49 days (38, 63) and 35 days (27, 39) for the 5 mg/kg and 3 mg/kg groups, respectively. This difference was statistically significant.</IndicationAndUsage>
    <Description>The chemical name of cidofovir USP is 1-[(S)-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine dihydrate (HPMPC), with the molecular formula of C8H14N3O6P2H2O and a molecular weight of 315.22 (279.19 for anhydrous). The chemical structure is. Cidofovir USP is a white crystalline powder with an aqueous solubility of ≥ 170 mg/mL at pH 6 to 8 and a log P (octanol/aqueous buffer, pH 7.1) value of -3.3. Cidofovir Injection, USP is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear and colorless. It is supplied in clear glass vials, each containing 375 mg of anhydrous cidofovir USP in 5 mL aqueous solution at a concentration of 75 mg/mL. The formulation is pH-adjusted to 7.4 (range 7.1 to 7.7)  with sodium hydroxide and/or hydrochloric acid and contains no preservatives. The appropriate volume of Cidofovir Injection must be removed from the single-dose vial and diluted prior to administration (see DOSAGE AND ADMINISTRATION). MICROBIOLOGY. Mechanism of Action. Cidofovir suppresses cytomegalovirus (CMV) replication by selective inhibition of viral DNA synthesis. Biochemical data support selective inhibition of CMV DNA polymerase by cidofovir diphosphate, the active intracellular metabolite of cidofovir. Cidofovir diphosphate inhibits herpesvirus polymerases at concentrations that are 8- to 600-fold lower than those needed to inhibit human cellular DNA polymerases alpha, beta, and gamma1, 2, 3. Incorporation of cidofovir into the growing viral DNA chain results in reductions in the rate of viral DNA synthesis. In Vitro Susceptibility. Cidofovir is active in vitro against a variety of laboratory and clinical isolates of CMV and other herpesviruses (Table 1). Controlled clinical studies of efficacy have been limited to patients with AIDS and CMV retinitis. Table 1. Cidofovir Inhibition of Virus Multiplication in Cell Culture. Resistance. CMV isolates with reduced susceptibility to cidofovir have been selected in vitro in the presence of high concentrations of cidofovir4. IC50 values for selected resistant isolates ranged from 7 to 15 μM. There are insufficient data at this time to assess the frequency or the clinical significance of the development of resistant isolates following cidofovir injection administration to patients. The possibility of viral resistance should be considered for patients who show a poor clinical response or experience recurrent retinitis progression during therapy. Cross Resistance. Cidofovir-resistant isolates selected in vitro following exposure to increasing concentrations of cidofovir were assessed for susceptibility to ganciclovir and foscarnet4. All were cross resistant to ganciclovir, but remained susceptible to foscarnet. Ganciclovir or ganciclovir/foscarnet-resistant isolates that are cross resistant to cidofovir have been obtained from drug naive patients and from patients following ganciclovir or ganciclovir/ foscarnet therapy. To date, the majority of ganciclovir-resistant isolates are UL97 gene product (phosphokinase) mutants and remain susceptible to cidofovir5. Reduced susceptibility to cidofovir, however, has been reported for DNA polymerase mutants of CMV which are resistant to ganciclovir6–9. To date, all clinical isolates which exhibit high level resistance to ganciclovir, due to mutations in both the DNA polymerase and UL97 genes, have been shown to be cross resistant to cidofovir. Cidofovir is active against some, but not all, CMV isolates which are resistant to foscarnet10–12. The incidence of foscarnet-resistant isolates that are resistant to cidofovir is not known. A few triple-drug resistant isolates have been described. Genotypic analysis of two of these triple-resistant isolates revealed several point mutations in the CMV DNA polymerase gene. The clinical significance of the development of these cross-resistant isolates is not known.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-107-06</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (33342-107-06)  / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0107-06</NDC11Code>
    <ProductNDC>33342-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risedronate Sodium</ProprietaryName>
    <NonProprietaryName>Risedronate Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203533</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISEDRONATE SODIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151209</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risedronate sodium tablet, USP is a bisphosphonate indicated for: 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget's disease (1.4).</IndicationAndUsage>
    <Description>Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablets, USP for oral administration contains the equivalent of 5, 30 and 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The molecular formula for risedronate sodium hemi-pentahydrate is C7H10NO7P2Na 2.5 H2O. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following. Molecular Weight. Anhydrous: 305.10. Hemi-pentahydrate: 350.13. Risedronate sodium anhydrous is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. All dose strengths contain: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. Dose strength-specific ingredients include: 5 mg-ferric oxide yellow, lactose anhydrous; 30 mg- lactose anhydrous; 35 mg-ferric oxide red, ferric oxide yellow, lactose anhydrous.</Description>
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  <NDC>
    <NDCCode>33342-107-07</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 CONTAINER (33342-107-07) </PackageDescription>
    <NDC11Code>33342-0107-07</NDC11Code>
    <ProductNDC>33342-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risedronate Sodium</ProprietaryName>
    <NonProprietaryName>Risedronate Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203533</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISEDRONATE SODIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151209</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risedronate sodium tablet, USP is a bisphosphonate indicated for: 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget's disease (1.4).</IndicationAndUsage>
    <Description>Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablets, USP for oral administration contains the equivalent of 5, 30 and 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The molecular formula for risedronate sodium hemi-pentahydrate is C7H10NO7P2Na 2.5 H2O. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following. Molecular Weight. Anhydrous: 305.10. Hemi-pentahydrate: 350.13. Risedronate sodium anhydrous is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. All dose strengths contain: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. Dose strength-specific ingredients include: 5 mg-ferric oxide yellow, lactose anhydrous; 30 mg- lactose anhydrous; 35 mg-ferric oxide red, ferric oxide yellow, lactose anhydrous.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-107-49</NDCCode>
    <PackageDescription>2000 TABLET, FILM COATED in 1 CONTAINER (33342-107-49) </PackageDescription>
    <NDC11Code>33342-0107-49</NDC11Code>
    <ProductNDC>33342-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risedronate Sodium</ProprietaryName>
    <NonProprietaryName>Risedronate Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203533</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>RISEDRONATE SODIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151209</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risedronate sodium tablet, USP is a bisphosphonate indicated for: 1 Treatment and prevention of postmenopausal osteoporosis (1.1), 2 Treatment to increase bone mass in men with osteoporosis (1.2) , 3 Treatment and prevention of glucocorticoid-induced osteoporosis (1.3) , 4 Treatment of Paget's disease (1.4).</IndicationAndUsage>
    <Description>Risedronate sodium tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablets, USP for oral administration contains the equivalent of 5, 30 and 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The molecular formula for risedronate sodium hemi-pentahydrate is C7H10NO7P2Na 2.5 H2O. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following. Molecular Weight. Anhydrous: 305.10. Hemi-pentahydrate: 350.13. Risedronate sodium anhydrous is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients. All dose strengths contain: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. Dose strength-specific ingredients include: 5 mg-ferric oxide yellow, lactose anhydrous; 30 mg- lactose anhydrous; 35 mg-ferric oxide red, ferric oxide yellow, lactose anhydrous.</Description>
  </NDC>
  <NDC>
    <NDCCode>45865-107-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (45865-107-30) </PackageDescription>
    <NDC11Code>45865-0107-30</NDC11Code>
    <ProductNDC>45865-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200702</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208677</ApplicationNumber>
    <LabelerName>Medsource Pharmaceuticals</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200702</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for:Pregabalin capsules are indicated for.  Management of neuropathic pain associated with diabetic peripheral neuropathy.  Management of postherpetic neuralgia.  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older.  Management of fibromyalgia.  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline powder with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&amp;C Blue 1, FD&amp;C Red 40 and FD&amp;C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>45865-107-90</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (45865-107-90) </PackageDescription>
    <NDC11Code>45865-0107-90</NDC11Code>
    <ProductNDC>45865-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200702</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208677</ApplicationNumber>
    <LabelerName>Medsource Pharmaceuticals</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200702</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsules are indicated for:Pregabalin capsules are indicated for.  Management of neuropathic pain associated with diabetic peripheral neuropathy.  Management of postherpetic neuralgia.  Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older.  Management of fibromyalgia.  Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
    <Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline powder with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&amp;C Blue 1, FD&amp;C Red 40 and FD&amp;C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>49348-107-17</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (49348-107-17)  &gt; 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>49348-0107-17</NDC11Code>
    <ProductNDC>49348-107</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Eye Itch Relief</ProprietaryName>
    <NonProprietaryName>Ketotifen Fumarate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20140207</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077958</ApplicationNumber>
    <LabelerName>STRATEGIC SOURCING SERVICES LLC</LabelerName>
    <SubstanceName>KETOTIFEN FUMARATE</SubstanceName>
    <StrengthNumber>.35</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55154-0120-5</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 BAG (55154-0120-5)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>55154-0120-05</NDC11Code>
    <ProductNDC>55154-0120</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20110727</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074802</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110727</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients. Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
    <Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti‑inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
  </NDC>
  <NDC>
    <NDCCode>55154-0199-0</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 BAG (55154-0199-0)  / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55154-0199-00</NDC11Code>
    <ProductNDC>55154-0199</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acyclovir</ProprietaryName>
    <NonProprietaryName>Acyclovir</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074889</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>ACYCLOVIR</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260514</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Herpes Zoster Infections: Acyclovir capsules are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes:  Acyclovir capsules are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir capsules are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
    <Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules, USP are a formulation for oral administration. Each capsule contains 200 mg of acyclovir, USP and the inactive ingredients, microcrystalline cellulose, povidone, sodium starch glycolate, pregelatinized starch and magnesium stearate. The capsule shell consists of gelatin, FD&amp;C Blue No. 2 and titanium dioxide. Printed with edible black ink with the following components: shellac, propylene glycol, ammonia solution, black iron oxide and potassium hydroxide. Acyclovir, USP is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action:. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
  </NDC>
  <NDC>
    <NDCCode>55154-1555-5</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 BAG (55154-1555-5)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>55154-1555-05</NDC11Code>
    <ProductNDC>55154-1555</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20200103</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204216</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).</IndicationAndUsage>
    <Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg and 8.70 mg respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear to slightly yellow in color.</Description>
  </NDC>
  <NDC>
    <NDCCode>55154-1556-5</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 BAG (55154-1556-5)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>55154-1556-05</NDC11Code>
    <ProductNDC>55154-1556</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20200103</StartMarketingDate>
    <EndMarketingDate>20241130</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204216</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200103</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).</IndicationAndUsage>
    <Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg and 8.70 mg respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear to slightly yellow in color.</Description>
  </NDC>
  <NDC>
    <NDCCode>55154-2637-0</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 BAG (55154-2637-0)  / 1 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55154-2637-00</NDC11Code>
    <ProductNDC>55154-2637</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20241021</StartMarketingDate>
    <EndMarketingDate>20250831</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075964</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20241021</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
  </NDC>
  <NDC>
    <NDCCode>55154-3329-0</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 BAG (55154-3329-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55154-3329-00</NDC11Code>
    <ProductNDC>55154-3329</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram</ProprietaryName>
    <NonProprietaryName>Citalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078216</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
    <Description>Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3‑dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP  20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone,  corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55154-3349-0</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 BAG (55154-3349-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55154-3349-00</NDC11Code>
    <ProductNDC>55154-3349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram</ProprietaryName>
    <NonProprietaryName>Citalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078216</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
    <Description>Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3‑dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP  20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone,  corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55154-6960-5</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 BAG (55154-6960-5)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>55154-6960-05</NDC11Code>
    <ProductNDC>55154-6960</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20110727</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074802</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110727</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients. Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
    <Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti‑inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
  </NDC>
  <NDC>
    <NDCCode>55154-7297-0</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 BAG (55154-7297-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55154-7297-00</NDC11Code>
    <ProductNDC>55154-7297</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mirtazapine</ProprietaryName>
    <NonProprietaryName>Mirtazapine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070822</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077666</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>MIRTAZAPINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20070822</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Mirtazapine tablets contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2‑-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine. Each tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. In addition, mirtazapine tablets, USP 15 mg and 30 mg contains iron oxide yellow and mirtazapine tablets, USP 30 mg contains iron oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>55154-7833-5</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-DOSE in 1 BAG (55154-7833-5)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>55154-7833-05</NDC11Code>
    <ProductNDC>55154-7833</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20260512</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074802</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260512</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients. Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</IndicationAndUsage>
    <Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti‑inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
  </NDC>
  <NDC>
    <NDCCode>55154-8335-6</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 BAG (55154-8335-6)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55154-8335-06</NDC11Code>
    <ProductNDC>55154-8335</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mirtazapine</ProprietaryName>
    <NonProprietaryName>Mirtazapine</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20051208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077376</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>MIRTAZAPINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-08-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20051208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Mirtazapine orally disintegrating tablet, USP contains mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine orally disintegrating tablets, USP are available for oral administration as an orally disintegrating tablet containing 15 mg, 30 mg or 45 mg of mirtazapine USP. Mirtazapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial peppermint flavor, and strawberry guarana flavor.</Description>
  </NDC>
  <NDC>
    <NDCCode>55154-9366-5</NDCCode>
    <PackageDescription>5 VIAL, SINGLE-USE in 1 BAG (55154-9366-5)  / 1 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>55154-9366-05</NDC11Code>
    <ProductNDC>55154-9366</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20010905</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075784</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).</IndicationAndUsage>
    <Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti- inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3- dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 0.1% citric acid, 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
  </NDC>
</NDCList>