RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>21130-758-53</NDCCode>
    <PackageDescription>500 TABLET, COATED in 1 BOTTLE (21130-758-53) </PackageDescription>
    <NDC11Code>21130-0758-53</NDC11Code>
    <ProductNDC>21130-758</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aspirin 325 Mg</ProprietaryName>
    <NonProprietaryName>Aspirin</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260105</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>BETTER LIVING BRANDS, LLC</LabelerName>
    <SubstanceName>ASPIRIN</SubstanceName>
    <StrengthNumber>325</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260105</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 temporarily relieves:.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51655-758-53</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (51655-758-53) </PackageDescription>
    <NDC11Code>51655-0758-53</NDC11Code>
    <ProductNDC>51655-758</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231004</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091179</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231012</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Promethazine hydrochloride tablets are useful for: 1 Perennial and seasonal allergic rhinitis., 2 Vasomotor rhinitis., 3 Allergic conjunctivitis due to inhalant allergens and foods., 4 Mild, uncomplicated allergic skin manifestations of urticaria and angioedema., 5 Amelioration of allergic reactions to blood or plasma., 6 Dermographism., 7 Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled., 8 Preoperative, postoperative and obstetric sedation., 9 Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery., 10 Therapy adjunctive to meperidine or other analgesics for control of postoperative pain., 11 Sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused., 12 Active and prophylactic treatment of motion sickness., 13 Antiemetic therapy in postoperative patients.</IndicationAndUsage>
    <Description>Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as (±)-10- [2-(Dimethylamino)propyl]phenothiazine monohydrochloride and has the following structural formula. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17H 20N 2S HCl and its molecular weight is 320.88 g/mol. Promethazine hydrochloride, USP occurs as a white to faint yellowish crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride, USP. The inactive ingredients include: lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The 50 mgalso contains D&amp;C Red # 27 Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-758-53</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (71610-758-53) </PackageDescription>
    <NDC11Code>71610-0758-53</NDC11Code>
    <ProductNDC>71610-758</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pregabalin</ProprietaryName>
    <NonProprietaryName>Pregabalin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209357</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>PREGABALIN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-12-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pregabalin capsule is indicated for. 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 C8H17NO2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1of 4.2 and a pKa2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with mannitol and talc as inactive ingredients. The capsule shells contain FD&amp;C Blue No. 2, gelatin, titanium dioxide, sodium lauryl sulfate and is imprinted with black ink. Black imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>21130-006-53</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (21130-006-53) </PackageDescription>
    <NDC11Code>21130-0006-53</NDC11Code>
    <ProductNDC>21130-006</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230622</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091239</ApplicationNumber>
    <LabelerName>BETTER LIVING BRANDS, LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230828</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. : 1 temporarily relieves minor aches and pains due to:.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21130-033-53</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (21130-033-53)  / 25 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>21130-0033-53</NDC11Code>
    <ProductNDC>21130-033</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230908</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206531</ApplicationNumber>
    <LabelerName>Better Living Brands, LLC</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230908</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>21130-160-53</NDCCode>
    <PackageDescription>12 BLISTER PACK in 1 CARTON (21130-160-53)  &gt; 2.5 g in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>21130-0160-53</NDC11Code>
    <ProductNDC>21130-160</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hemorrhoidal</ProprietaryName>
    <NonProprietaryName>Cocoa Butter, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>SUPPOSITORY</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20121113</StartMarketingDate>
    <EndMarketingDate>20171228</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part346</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.135; .0065</StrengthNumber>
    <StrengthUnit>g/2.5g; g/2.5g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>21130-176-53</NDCCode>
    <PackageDescription>12 BLISTER PACK in 1 CARTON (21130-176-53)  &gt; 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>21130-0176-53</NDC11Code>
    <ProductNDC>21130-176</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Signature Care Allergy Relief D</ProprietaryName>
    <NonProprietaryName>Cetirizine Hcl, Pseudoephedrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151015</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077170</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 120</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180912</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. nasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21130-261-53</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (21130-261-53) </PackageDescription>
    <NDC11Code>21130-0261-53</NDC11Code>
    <ProductNDC>21130-261</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091239</ApplicationNumber>
    <LabelerName>BETTER LIVING BRANDS, LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. : 1 temporarily relieves minor aches and pains due to:.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21130-279-53</NDCCode>
    <PackageDescription>12 BLISTER PACK in 1 CARTON (21130-279-53)  &gt; 1 SUPPOSITORY in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>21130-0279-53</NDC11Code>
    <ProductNDC>21130-279</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hemorrhoidal</ProprietaryName>
    <NonProprietaryName>Cocoa Butter, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>SUPPOSITORY</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20141007</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part346</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2211; 6.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-13</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>21130-628-53</NDCCode>
    <PackageDescription>12 BLISTER PACK in 1 CARTON (21130-628-53)  &gt; 1 SUPPOSITORY in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>21130-0628-53</NDC11Code>
    <ProductNDC>21130-628</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Signature Care Hemorrhoidal</ProprietaryName>
    <NonProprietaryName>Cocoa Butter, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>SUPPOSITORY</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20151103</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part346</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2211; 6.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151103</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps relieve the local itching and discomfort associated with hemorrhoids. temporarily relieves burning and shrinks hemorrhoidal tissue. temporarily provides a coating for relief of anorectal discomforts. temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>21130-992-53</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (21130-992-53) </PackageDescription>
    <NDC11Code>21130-0992-53</NDC11Code>
    <ProductNDC>21130-992</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen Tablets Usp, 200mg</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230808</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091237</ApplicationNumber>
    <LabelerName>BETTER LIVING BRANDS, LLC</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230808</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0054-0237-49</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (0054-0237-49) </PackageDescription>
    <NDC11Code>00054-0237-49</NDC11Code>
    <ProductNDC>0054-0237</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080317</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022195</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of: : 1 adults with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. , 2 pediatric patients 2 years of age and older with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
    <Description>Morphine Sulfate Oral Solution is an opioid agonist, available in the following concentrations for oral administration: 1 10 mg per 5 mL (2 mg/mL): Each 1 mL of oral solution contains 2 mg of morphine sulfate, USP (equivalent to 1.5 mg morphine). , 2 20 mg per 5 mL (4 mg/mL): Each 1 mL of oral solution contains 4 mg of morphine sulfate, USP (equivalent to 3 mg morphine)., 3 100 mg per 5 mL (20 mg/mL): Each 1 mL of oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine).The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H21NO3)2H2SO4, and it has the following chemical structure.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0237-63</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE (0054-0237-63) </PackageDescription>
    <NDC11Code>00054-0237-63</NDC11Code>
    <ProductNDC>0054-0237</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080317</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022195</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of: : 1 adults with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. , 2 pediatric patients 2 years of age and older with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
    <Description>Morphine Sulfate Oral Solution is an opioid agonist, available in the following concentrations for oral administration: 1 10 mg per 5 mL (2 mg/mL): Each 1 mL of oral solution contains 2 mg of morphine sulfate, USP (equivalent to 1.5 mg morphine). , 2 20 mg per 5 mL (4 mg/mL): Each 1 mL of oral solution contains 4 mg of morphine sulfate, USP (equivalent to 3 mg morphine)., 3 100 mg per 5 mL (20 mg/mL): Each 1 mL of oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine).The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H21NO3)2H2SO4, and it has the following chemical structure.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0238-49</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (0054-0238-49) </PackageDescription>
    <NDC11Code>00054-0238-49</NDC11Code>
    <ProductNDC>0054-0238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080317</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022195</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of: : 1 adults with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. , 2 pediatric patients 2 years of age and older with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
    <Description>Morphine Sulfate Oral Solution is an opioid agonist, available in the following concentrations for oral administration: 1 10 mg per 5 mL (2 mg/mL): Each 1 mL of oral solution contains 2 mg of morphine sulfate, USP (equivalent to 1.5 mg morphine). , 2 20 mg per 5 mL (4 mg/mL): Each 1 mL of oral solution contains 4 mg of morphine sulfate, USP (equivalent to 3 mg morphine)., 3 100 mg per 5 mL (20 mg/mL): Each 1 mL of oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine).The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H21NO3)2H2SO4, and it has the following chemical structure.</Description>
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  <NDC>
    <NDCCode>0054-0238-63</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE (0054-0238-63) </PackageDescription>
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    <ProductNDC>0054-0238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
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    <StartMarketingDate>20080317</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
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    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080317</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of: : 1 adults with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. , 2 pediatric patients 2 years of age and older with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
    <Description>Morphine Sulfate Oral Solution is an opioid agonist, available in the following concentrations for oral administration: 1 10 mg per 5 mL (2 mg/mL): Each 1 mL of oral solution contains 2 mg of morphine sulfate, USP (equivalent to 1.5 mg morphine). , 2 20 mg per 5 mL (4 mg/mL): Each 1 mL of oral solution contains 4 mg of morphine sulfate, USP (equivalent to 3 mg morphine)., 3 100 mg per 5 mL (20 mg/mL): Each 1 mL of oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine).The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H21NO3)2H2SO4, and it has the following chemical structure.</Description>
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  <NDC>
    <NDCCode>0054-0517-41</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE (0054-0517-41) </PackageDescription>
    <NDC11Code>00054-0517-41</NDC11Code>
    <ProductNDC>0054-0517</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080317</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022195</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150810</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of: : 1 adults with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. , 2 pediatric patients 2 years of age and older with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
    <Description>Morphine Sulfate Oral Solution is an opioid agonist, available in the following concentrations for oral administration: 1 10 mg per 5 mL (2 mg/mL): Each 1 mL of oral solution contains 2 mg of morphine sulfate, USP (equivalent to 1.5 mg morphine). , 2 20 mg per 5 mL (4 mg/mL): Each 1 mL of oral solution contains 4 mg of morphine sulfate, USP (equivalent to 3 mg morphine)., 3 100 mg per 5 mL (20 mg/mL): Each 1 mL of oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine).The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H21NO3)2H2SO4, and it has the following chemical structure.</Description>
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    <NDCCode>0054-0517-44</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE (0054-0517-44) </PackageDescription>
    <NDC11Code>00054-0517-44</NDC11Code>
    <ProductNDC>0054-0517</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080317</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022195</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150810</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of: : 1 adults with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. , 2 pediatric patients 2 years of age and older with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
    <Description>Morphine Sulfate Oral Solution is an opioid agonist, available in the following concentrations for oral administration: 1 10 mg per 5 mL (2 mg/mL): Each 1 mL of oral solution contains 2 mg of morphine sulfate, USP (equivalent to 1.5 mg morphine). , 2 20 mg per 5 mL (4 mg/mL): Each 1 mL of oral solution contains 4 mg of morphine sulfate, USP (equivalent to 3 mg morphine)., 3 100 mg per 5 mL (20 mg/mL): Each 1 mL of oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine).The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H21NO3)2H2SO4, and it has the following chemical structure.</Description>
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    <NDCCode>0054-0517-50</NDCCode>
    <PackageDescription>120 mL in 1 BOTTLE (0054-0517-50) </PackageDescription>
    <NDC11Code>00054-0517-50</NDC11Code>
    <ProductNDC>0054-0517</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080317</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022195</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150810</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of: : 1 adults with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. , 2 pediatric patients 2 years of age and older with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
    <Description>Morphine Sulfate Oral Solution is an opioid agonist, available in the following concentrations for oral administration: 1 10 mg per 5 mL (2 mg/mL): Each 1 mL of oral solution contains 2 mg of morphine sulfate, USP (equivalent to 1.5 mg morphine). , 2 20 mg per 5 mL (4 mg/mL): Each 1 mL of oral solution contains 4 mg of morphine sulfate, USP (equivalent to 3 mg morphine)., 3 100 mg per 5 mL (20 mg/mL): Each 1 mL of oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine).The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H21NO3)2H2SO4, and it has the following chemical structure.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1277-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1277-01) </PackageDescription>
    <NDC11Code>00115-1277-01</NDC11Code>
    <ProductNDC>0115-1277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160412</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200411</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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 morphine sulfate extended-release capsules for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release capsules are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Morphine Sulfate Extended-Release Capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin and titanium dioxide. In addition, the 20 mg and 40 mg capsule shells contain yellow iron oxide; the 30 mg and 40 mg capsule shells contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3; the 50 mg capsule shell contains FD&amp;C Blue No. 1; the 60 mg capsule shell contains FD&amp;C Red No. 40; the 80 mg capsule shell contains D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40; and the 100 mg capsule shell contains D&amp;C Yellow No. 10 and FD&amp;C Green No. 3. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1277-03</NDCCode>
    <PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1277-03) </PackageDescription>
    <NDC11Code>00115-1277-03</NDC11Code>
    <ProductNDC>0115-1277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160412</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200411</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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 morphine sulfate extended-release capsules for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release capsules are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Morphine Sulfate Extended-Release Capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin and titanium dioxide. In addition, the 20 mg and 40 mg capsule shells contain yellow iron oxide; the 30 mg and 40 mg capsule shells contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3; the 50 mg capsule shell contains FD&amp;C Blue No. 1; the 60 mg capsule shell contains FD&amp;C Red No. 40; the 80 mg capsule shell contains D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40; and the 100 mg capsule shell contains D&amp;C Yellow No. 10 and FD&amp;C Green No. 3. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1277-08</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1277-08) </PackageDescription>
    <NDC11Code>00115-1277-08</NDC11Code>
    <ProductNDC>0115-1277</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160412</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200411</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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 morphine sulfate extended-release capsules for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release capsules are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Morphine Sulfate Extended-Release Capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin and titanium dioxide. In addition, the 20 mg and 40 mg capsule shells contain yellow iron oxide; the 30 mg and 40 mg capsule shells contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3; the 50 mg capsule shell contains FD&amp;C Blue No. 1; the 60 mg capsule shell contains FD&amp;C Red No. 40; the 80 mg capsule shell contains D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40; and the 100 mg capsule shell contains D&amp;C Yellow No. 10 and FD&amp;C Green No. 3. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1278-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1278-01) </PackageDescription>
    <NDC11Code>00115-1278-01</NDC11Code>
    <ProductNDC>0115-1278</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160412</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200411</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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 morphine sulfate extended-release capsules for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release capsules are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Morphine Sulfate Extended-Release Capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin and titanium dioxide. In addition, the 20 mg and 40 mg capsule shells contain yellow iron oxide; the 30 mg and 40 mg capsule shells contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3; the 50 mg capsule shell contains FD&amp;C Blue No. 1; the 60 mg capsule shell contains FD&amp;C Red No. 40; the 80 mg capsule shell contains D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40; and the 100 mg capsule shell contains D&amp;C Yellow No. 10 and FD&amp;C Green No. 3. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is.</Description>
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    <IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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 morphine sulfate extended-release capsules for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release capsules are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Morphine Sulfate Extended-Release Capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin and titanium dioxide. In addition, the 20 mg and 40 mg capsule shells contain yellow iron oxide; the 30 mg and 40 mg capsule shells contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3; the 50 mg capsule shell contains FD&amp;C Blue No. 1; the 60 mg capsule shell contains FD&amp;C Red No. 40; the 80 mg capsule shell contains D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40; and the 100 mg capsule shell contains D&amp;C Yellow No. 10 and FD&amp;C Green No. 3. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is.</Description>
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    <Description>Morphine Sulfate Extended-Release Capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin and titanium dioxide. In addition, the 20 mg and 40 mg capsule shells contain yellow iron oxide; the 30 mg and 40 mg capsule shells contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3; the 50 mg capsule shell contains FD&amp;C Blue No. 1; the 60 mg capsule shell contains FD&amp;C Red No. 40; the 80 mg capsule shell contains D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40; and the 100 mg capsule shell contains D&amp;C Yellow No. 10 and FD&amp;C Green No. 3. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is.</Description>
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    <Description>Morphine Sulfate Extended-Release Capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin and titanium dioxide. In addition, the 20 mg and 40 mg capsule shells contain yellow iron oxide; the 30 mg and 40 mg capsule shells contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3; the 50 mg capsule shell contains FD&amp;C Blue No. 1; the 60 mg capsule shell contains FD&amp;C Red No. 40; the 80 mg capsule shell contains D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40; and the 100 mg capsule shell contains D&amp;C Yellow No. 10 and FD&amp;C Green No. 3. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is.</Description>
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    <IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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 morphine sulfate extended-release capsules for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release capsules are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Morphine Sulfate Extended-Release Capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin and titanium dioxide. In addition, the 20 mg and 40 mg capsule shells contain yellow iron oxide; the 30 mg and 40 mg capsule shells contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3; the 50 mg capsule shell contains FD&amp;C Blue No. 1; the 60 mg capsule shell contains FD&amp;C Red No. 40; the 80 mg capsule shell contains D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40; and the 100 mg capsule shell contains D&amp;C Yellow No. 10 and FD&amp;C Green No. 3. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is.</Description>
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    <Description>Morphine Sulfate Extended-Release Capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin and titanium dioxide. In addition, the 20 mg and 40 mg capsule shells contain yellow iron oxide; the 30 mg and 40 mg capsule shells contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3; the 50 mg capsule shell contains FD&amp;C Blue No. 1; the 60 mg capsule shell contains FD&amp;C Red No. 40; the 80 mg capsule shell contains D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40; and the 100 mg capsule shell contains D&amp;C Yellow No. 10 and FD&amp;C Green No. 3. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is.</Description>
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    <Description>Morphine Sulfate Extended-Release Capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin and titanium dioxide. In addition, the 20 mg and 40 mg capsule shells contain yellow iron oxide; the 30 mg and 40 mg capsule shells contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3; the 50 mg capsule shell contains FD&amp;C Blue No. 1; the 60 mg capsule shell contains FD&amp;C Red No. 40; the 80 mg capsule shell contains D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40; and the 100 mg capsule shell contains D&amp;C Yellow No. 10 and FD&amp;C Green No. 3. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is.</Description>
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    <StartMarketingDatePackage>20160412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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 morphine sulfate extended-release capsules for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release capsules are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Morphine Sulfate Extended-Release Capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin and titanium dioxide. In addition, the 20 mg and 40 mg capsule shells contain yellow iron oxide; the 30 mg and 40 mg capsule shells contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3; the 50 mg capsule shell contains FD&amp;C Blue No. 1; the 60 mg capsule shell contains FD&amp;C Red No. 40; the 80 mg capsule shell contains D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40; and the 100 mg capsule shell contains D&amp;C Yellow No. 10 and FD&amp;C Green No. 3. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0115-1280-08</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1280-08) </PackageDescription>
    <NDC11Code>00115-1280-08</NDC11Code>
    <ProductNDC>0115-1280</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160412</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200411</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-01-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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 morphine sulfate extended-release capsules for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release capsules are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Morphine Sulfate Extended-Release Capsules, USP, an opioid agonist, are for oral use and contain pellets of morphine sulfate. Each morphine sulfate extended-release capsule, USP contains either 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 80 mg, or 100 mg of morphine sulfate, USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose. The capsule shells contain gelatin and titanium dioxide. In addition, the 20 mg and 40 mg capsule shells contain yellow iron oxide; the 30 mg and 40 mg capsule shells contain FD&amp;C Blue No. 1 and FD&amp;C Red No. 3; the 50 mg capsule shell contains FD&amp;C Blue No. 1; the 60 mg capsule shell contains FD&amp;C Red No. 40; the 80 mg capsule shell contains D&amp;C Red No. 28, D&amp;C Yellow No. 10, and FD&amp;C Red No. 40; and the 100 mg capsule shell contains D&amp;C Yellow No. 10 and FD&amp;C Green No. 3. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The chemical name of morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate. The molecular formula is (C17H19NO3)2∙H2SO4∙5H2O and its molecular weight is 758.85. Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is.</Description>
  </NDC>
</NDCList>