RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>50742-376-04</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (50742-376-04)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
    <NDC11Code>50742-0376-04</NDC11Code>
    <ProductNDC>50742-376</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buprenorphine</ProprietaryName>
    <NonProprietaryName>Buprenorphine</NonProprietaryName>
    <DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210272</ApplicationNumber>
    <LabelerName>INGENUS PHARMACEUTICALS, LLC</LabelerName>
    <SubstanceName>BUPRENORPHINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>ug/h</StrengthUnit>
    <Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buprenorphine transdermal system is 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 buprenorphine transdermal system, 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 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is (5 R,6 R,7 R,9 R,13 S,14 S)-17-Cyclopropylmethyl-7-[( S)-3,3-dimethyl-2-hydroxybutan-2-yl]-6-methoxy-4,5-epoxy-6,14-ethanomorphinan-3-ol. The structural formula is:. The molecular weight of buprenorphine is 467.64; the empirical formula is C 29H 41NO 4. Buprenorphine occurs as a white or almost white crystalline powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol, and slightly soluble in cyclohexane. It dissolves in dilute solutions of acids. The pKa is 8.35 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Table 6: Buprenorphine Transdermal System Product Specifications. Buprenorphine transdermal system is a rectangular or square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate cross-linked with aluminum.</Description>
  </NDC>
  <NDC>
    <NDCCode>55312-376-04</NDCCode>
    <PackageDescription>177 mL in 1 BOTTLE, SPRAY (55312-376-04) </PackageDescription>
    <NDC11Code>55312-0376-04</NDC11Code>
    <ProductNDC>55312-376</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sore Throat Relief</ProprietaryName>
    <NonProprietaryName>Phenol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140630</StartMarketingDate>
    <EndMarketingDate>20191231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Western Family Foods, Inc.</LabelerName>
    <SubstanceName>PHENOL</SubstanceName>
    <StrengthNumber>1.4</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140630</StartMarketingDatePackage>
    <EndMarketingDatePackage>20191231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62282-376-04</NDCCode>
    <PackageDescription>237 mL in 1 BOTTLE, PUMP (62282-376-04) </PackageDescription>
    <NDC11Code>62282-0376-04</NDC11Code>
    <ProductNDC>62282-376</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunbetter Broad Spectrum Spf 75 Sunscreen Tone Smart</ProprietaryName>
    <NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Northwest Cosmetic Laboratories LLC, D.B.A. Elevation Labs Idaho</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>35; 100</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63323-376-04</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 TRAY (63323-376-04)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-376-41) </PackageDescription>
    <NDC11Code>63323-0376-04</NDC11Code>
    <ProductNDC>63323-376</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Octreotide</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20060314</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077457</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>OCTREOTIDE ACETATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060314</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Octreotide Acetate Injection is a somatostatin analogue indicated: : 1 Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1.1) , 2 Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1.2) , 3 Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. (1.3) .</IndicationAndUsage>
    <Description>Octreotide Acetate Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered acetate solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-, cyclic (2→7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Octreotide Acetate Injection is available as: sterile 1 mL single dose vials in 2 strengths, containing 100 mcg and 500 mcg octreotide (as acetate). Each mL of the single dose vial also contains: : 1   sodium chloride…………………..……... 7 mg , 2   glacial acetic acid, USP ………………… 2 mg , 3   sodium acetate trihydrate, USP ………… 2 mg , 4   water for injection, USP ……………qs to 1 mL .</Description>
  </NDC>
  <NDC>
    <NDCCode>65585-376-04</NDCCode>
    <PackageDescription>208.2 L in 1 DRUM (65585-376-04) </PackageDescription>
    <NDC11Code>65585-0376-04</NDC11Code>
    <ProductNDC>65585-376</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Whiskcare 375 Fragrance Free</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20091001</StartMarketingDate>
    <EndMarketingDate>20251231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Whisk Products, Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200322</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitizer to help reduce amount of bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>67091-376-04</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (67091-376-04)  &gt; 118 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>67091-0376-04</NDC11Code>
    <ProductNDC>67091-376</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Childrens Pain Relief Oral Suspension Dye Free</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210918</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>WinCo Foods, LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210918</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>84525-376-04</NDCCode>
    <PackageDescription>50 g in 1 BOX (84525-376-04) </PackageDescription>
    <NDC11Code>84525-0376-04</NDC11Code>
    <ProductNDC>84525-376</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Trstay Moisturizing Body Cream</ProprietaryName>
    <NonProprietaryName>Trstay Moisturizing Body Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250110</StartMarketingDate>
    <EndMarketingDate>20310110</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20250110</StartMarketingDatePackage>
    <EndMarketingDatePackage>20310110</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84756-376-04</NDCCode>
    <PackageDescription>50 g in 1 BOX (84756-376-04) </PackageDescription>
    <NDC11Code>84756-0376-04</NDC11Code>
    <ProductNDC>84756-376</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Urea Cream</ProprietaryName>
    <NonProprietaryName>Urea Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241120</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50742-287-60</NDCCode>
    <PackageDescription>15 POUCH in 1 CARTON (50742-287-60)  / 4 CONTAINER in 1 POUCH (50742-287-04)  / .3 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>50742-0287-60</NDC11Code>
    <ProductNDC>50742-287</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Maleate</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20220915</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216533</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>3.4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Preservative-free timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.</IndicationAndUsage>
    <Description>Timolol maleate, USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is. (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate, USP possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4, and its structural formula is. Timolol maleate, USP has a molecular weight of 432.50. It is a white, or practically white, odorless or practically odorless powder which is soluble in water, in alcohol, and in methanol; sparingly soluble in chloroform and in propylene glycol; insoluble in ether and in cyclohexane. Timolol maleate, USP is stable at room temperature. Timolol maleate ophthalmic solution, USP is supplied in preservative-free formulation. Preservative-free timolol maleate ophthalmic solution, USP is supplied in a single-dose vial, as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of preservative-free timolol maleate ophthalmic solution USP, 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of preservative-free timolol maleate ophthalmic solution USP, 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic sodium phosphate dihydrate and dibasic sodium phosphate dodecahydrate, sodium hydroxide to adjust pH, and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>50742-288-60</NDCCode>
    <PackageDescription>15 POUCH in 1 CARTON (50742-288-60)  / 4 CONTAINER in 1 POUCH (50742-288-04)  / .3 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>50742-0288-60</NDC11Code>
    <ProductNDC>50742-288</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Maleate</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20220915</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216533</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>6.8</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Preservative-free timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.</IndicationAndUsage>
    <Description>Timolol maleate, USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is. (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate, USP possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4, and its structural formula is. Timolol maleate, USP has a molecular weight of 432.50. It is a white, or practically white, odorless or practically odorless powder which is soluble in water, in alcohol, and in methanol; sparingly soluble in chloroform and in propylene glycol; insoluble in ether and in cyclohexane. Timolol maleate, USP is stable at room temperature. Timolol maleate ophthalmic solution, USP is supplied in preservative-free formulation. Preservative-free timolol maleate ophthalmic solution, USP is supplied in a single-dose vial, as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of preservative-free timolol maleate ophthalmic solution USP, 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of preservative-free timolol maleate ophthalmic solution USP, 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic sodium phosphate dihydrate and dibasic sodium phosphate dodecahydrate, sodium hydroxide to adjust pH, and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>50742-372-04</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (50742-372-04)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
    <NDC11Code>50742-0372-04</NDC11Code>
    <ProductNDC>50742-372</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buprenorphine</ProprietaryName>
    <NonProprietaryName>Buprenorphine</NonProprietaryName>
    <DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210272</ApplicationNumber>
    <LabelerName>INGENUS PHARMACEUTICALS, LLC</LabelerName>
    <SubstanceName>BUPRENORPHINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>ug/h</StrengthUnit>
    <Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buprenorphine transdermal system is 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 buprenorphine transdermal system, 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 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is (5 R,6 R,7 R,9 R,13 S,14 S)-17-Cyclopropylmethyl-7-[( S)-3,3-dimethyl-2-hydroxybutan-2-yl]-6-methoxy-4,5-epoxy-6,14-ethanomorphinan-3-ol. The structural formula is:. The molecular weight of buprenorphine is 467.64; the empirical formula is C 29H 41NO 4. Buprenorphine occurs as a white or almost white crystalline powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol, and slightly soluble in cyclohexane. It dissolves in dilute solutions of acids. The pKa is 8.35 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Table 6: Buprenorphine Transdermal System Product Specifications. Buprenorphine transdermal system is a rectangular or square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate cross-linked with aluminum.</Description>
  </NDC>
  <NDC>
    <NDCCode>50742-373-04</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (50742-373-04)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
    <NDC11Code>50742-0373-04</NDC11Code>
    <ProductNDC>50742-373</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buprenorphine</ProprietaryName>
    <NonProprietaryName>Buprenorphine</NonProprietaryName>
    <DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210272</ApplicationNumber>
    <LabelerName>INGENUS PHARMACEUTICALS, LLC</LabelerName>
    <SubstanceName>BUPRENORPHINE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>ug/h</StrengthUnit>
    <Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buprenorphine transdermal system is 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 buprenorphine transdermal system, 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 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is (5 R,6 R,7 R,9 R,13 S,14 S)-17-Cyclopropylmethyl-7-[( S)-3,3-dimethyl-2-hydroxybutan-2-yl]-6-methoxy-4,5-epoxy-6,14-ethanomorphinan-3-ol. The structural formula is:. The molecular weight of buprenorphine is 467.64; the empirical formula is C 29H 41NO 4. Buprenorphine occurs as a white or almost white crystalline powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol, and slightly soluble in cyclohexane. It dissolves in dilute solutions of acids. The pKa is 8.35 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Table 6: Buprenorphine Transdermal System Product Specifications. Buprenorphine transdermal system is a rectangular or square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate cross-linked with aluminum.</Description>
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  <NDC>
    <NDCCode>50742-374-04</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (50742-374-04)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
    <NDC11Code>50742-0374-04</NDC11Code>
    <ProductNDC>50742-374</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buprenorphine</ProprietaryName>
    <NonProprietaryName>Buprenorphine</NonProprietaryName>
    <DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210272</ApplicationNumber>
    <LabelerName>INGENUS PHARMACEUTICALS, LLC</LabelerName>
    <SubstanceName>BUPRENORPHINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>ug/h</StrengthUnit>
    <Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buprenorphine transdermal system is 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 buprenorphine transdermal system, 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 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is (5 R,6 R,7 R,9 R,13 S,14 S)-17-Cyclopropylmethyl-7-[( S)-3,3-dimethyl-2-hydroxybutan-2-yl]-6-methoxy-4,5-epoxy-6,14-ethanomorphinan-3-ol. The structural formula is:. The molecular weight of buprenorphine is 467.64; the empirical formula is C 29H 41NO 4. Buprenorphine occurs as a white or almost white crystalline powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol, and slightly soluble in cyclohexane. It dissolves in dilute solutions of acids. The pKa is 8.35 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Table 6: Buprenorphine Transdermal System Product Specifications. Buprenorphine transdermal system is a rectangular or square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate cross-linked with aluminum.</Description>
  </NDC>
  <NDC>
    <NDCCode>50742-375-04</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (50742-375-04)  / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
    <NDC11Code>50742-0375-04</NDC11Code>
    <ProductNDC>50742-375</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Buprenorphine</ProprietaryName>
    <NonProprietaryName>Buprenorphine</NonProprietaryName>
    <DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210272</ApplicationNumber>
    <LabelerName>INGENUS PHARMACEUTICALS, LLC</LabelerName>
    <SubstanceName>BUPRENORPHINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>ug/h</StrengthUnit>
    <Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Buprenorphine transdermal system is 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 buprenorphine transdermal system, 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 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is (5 R,6 R,7 R,9 R,13 S,14 S)-17-Cyclopropylmethyl-7-[( S)-3,3-dimethyl-2-hydroxybutan-2-yl]-6-methoxy-4,5-epoxy-6,14-ethanomorphinan-3-ol. The structural formula is:. The molecular weight of buprenorphine is 467.64; the empirical formula is C 29H 41NO 4. Buprenorphine occurs as a white or almost white crystalline powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol, and slightly soluble in cyclohexane. It dissolves in dilute solutions of acids. The pKa is 8.35 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Table 6: Buprenorphine Transdermal System Product Specifications. Buprenorphine transdermal system is a rectangular or square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate cross-linked with aluminum.</Description>
  </NDC>
  <NDC>
    <NDCCode>50742-505-04</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (50742-505-04)  / 1 PATCH, EXTENDED RELEASE in 1 POUCH</PackageDescription>
    <NDC11Code>50742-0505-04</NDC11Code>
    <ProductNDC>50742-505</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Scopolamine</ProprietaryName>
    <NonProprietaryName>Scopolamine</NonProprietaryName>
    <DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20201124</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212342</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>SCOPOLAMINE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201124</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
    <Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.5 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2 phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film printed with brown ink; (2) a drug adhesive layer of scopolamine, acrylic adhesive and isopropyl myristate; (3) an ethylene vinyl acetate membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a drug adhesive layer of scopolamine, acrylic adhesive and isopropyl myristate. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. The brown imprinting ink contains FD&amp;C yellow no. 6 aluminum lake, polyamide resin, polytetrafluoroethylene, polyethylene wax, carbon black and quinacridone red pigment. Cross section of the system.</Description>
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  <NDC>
    <NDCCode>50742-665-04</NDCCode>
    <PackageDescription>118 mL in 1 BOTTLE (50742-665-04) </PackageDescription>
    <NDC11Code>50742-0665-04</NDC11Code>
    <ProductNDC>50742-665</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</ProprietaryName>
    <NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName>
    <DosageFormName>ELIXIR</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210801</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir - Grape Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:  Phenobarbital, USP................................. 16.2 mg  Hyoscyamine Sulfate, USP................ 0.1037 mg  Atropine Sulfate, USP......................... 0.0194 mg  Scopolamine Hydrobromide, USP.... 0.0065 mgInactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&amp;C Red #3, and FD&amp;C Blue #1.Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir – Mint Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:  Phenobarbital, USP................................. 16.2 mg  Hyoscyamine Sulfate, USP................ 0.1037 mg  Atropine Sulfate, USP......................... 0.0194 mg  Scopolamine Hydrobromide, USP.... 0.0065 mgInactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&amp;C Yellow #5, and FD&amp;C Blue #1.</Description>
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  <NDC>
    <NDCCode>50742-666-04</NDCCode>
    <PackageDescription>118 mL in 1 BOTTLE (50742-666-04) </PackageDescription>
    <NDC11Code>50742-0666-04</NDC11Code>
    <ProductNDC>50742-666</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</ProprietaryName>
    <NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName>
    <DosageFormName>ELIXIR</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210801</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir - Grape Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:  Phenobarbital, USP................................. 16.2 mg  Hyoscyamine Sulfate, USP................ 0.1037 mg  Atropine Sulfate, USP......................... 0.0194 mg  Scopolamine Hydrobromide, USP.... 0.0065 mgInactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&amp;C Red #3, and FD&amp;C Blue #1.Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir – Mint Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:  Phenobarbital, USP................................. 16.2 mg  Hyoscyamine Sulfate, USP................ 0.1037 mg  Atropine Sulfate, USP......................... 0.0194 mg  Scopolamine Hydrobromide, USP.... 0.0065 mgInactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&amp;C Yellow #5, and FD&amp;C Blue #1.</Description>
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  <NDC>
    <NDCCode>50742-152-90</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50742-152-90)  &gt; 90 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>50742-0152-90</NDC11Code>
    <ProductNDC>50742-152</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Modafinil</ProprietaryName>
    <NonProprietaryName>Modafinil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140401</StartMarketingDate>
    <EndMarketingDate>20191231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078963</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>MODAFINIL</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20140401</StartMarketingDatePackage>
    <EndMarketingDatePackage>20190831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>50742-181-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (50742-181-01) </PackageDescription>
    <NDC11Code>50742-0181-01</NDC11Code>
    <ProductNDC>50742-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200730</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211132</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200730</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium), each 10 mg tablet contains 10 mg of leucovorin (equivalent to 10.8 mg of leucovorin calcium), each 15 mg tablet contains 15 mg of leucovorin (equivalent to 16.2 mg of leucovorin calcium) and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium). The 5 mg, 10 mg, 15 mg and 25 mg tablets contain the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Additionally, the 15 mg and 25 mg tablets contains FD&amp;C yellow #6.</Description>
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    <PackageDescription>30 TABLET in 1 BOTTLE (50742-181-30) </PackageDescription>
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    <ApplicationNumber>ANDA211132</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
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    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200730</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium), each 10 mg tablet contains 10 mg of leucovorin (equivalent to 10.8 mg of leucovorin calcium), each 15 mg tablet contains 15 mg of leucovorin (equivalent to 16.2 mg of leucovorin calcium) and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium). The 5 mg, 10 mg, 15 mg and 25 mg tablets contain the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Additionally, the 15 mg and 25 mg tablets contains FD&amp;C yellow #6.</Description>
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  <NDC>
    <NDCCode>50742-182-12</NDCCode>
    <PackageDescription>12 TABLET in 1 BOTTLE (50742-182-12) </PackageDescription>
    <NDC11Code>50742-0182-12</NDC11Code>
    <ProductNDC>50742-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200730</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211132</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200730</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium), each 10 mg tablet contains 10 mg of leucovorin (equivalent to 10.8 mg of leucovorin calcium), each 15 mg tablet contains 15 mg of leucovorin (equivalent to 16.2 mg of leucovorin calcium) and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium). The 5 mg, 10 mg, 15 mg and 25 mg tablets contain the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Additionally, the 15 mg and 25 mg tablets contains FD&amp;C yellow #6.</Description>
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  <NDC>
    <NDCCode>50742-182-24</NDCCode>
    <PackageDescription>24 TABLET in 1 BOTTLE (50742-182-24) </PackageDescription>
    <NDC11Code>50742-0182-24</NDC11Code>
    <ProductNDC>50742-182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200730</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211132</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200730</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium), each 10 mg tablet contains 10 mg of leucovorin (equivalent to 10.8 mg of leucovorin calcium), each 15 mg tablet contains 15 mg of leucovorin (equivalent to 16.2 mg of leucovorin calcium) and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium). The 5 mg, 10 mg, 15 mg and 25 mg tablets contain the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Additionally, the 15 mg and 25 mg tablets contains FD&amp;C yellow #6.</Description>
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  <NDC>
    <NDCCode>50742-183-24</NDCCode>
    <PackageDescription>24 TABLET in 1 BOTTLE (50742-183-24) </PackageDescription>
    <NDC11Code>50742-0183-24</NDC11Code>
    <ProductNDC>50742-183</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200730</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211132</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200730</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium), each 10 mg tablet contains 10 mg of leucovorin (equivalent to 10.8 mg of leucovorin calcium), each 15 mg tablet contains 15 mg of leucovorin (equivalent to 16.2 mg of leucovorin calcium) and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium). The 5 mg, 10 mg, 15 mg and 25 mg tablets contain the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Additionally, the 15 mg and 25 mg tablets contains FD&amp;C yellow #6.</Description>
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    <PackageDescription>25 TABLET in 1 BOTTLE (50742-184-25) </PackageDescription>
    <NDC11Code>50742-0184-25</NDC11Code>
    <ProductNDC>50742-184</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200730</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211132</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200730</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium), each 10 mg tablet contains 10 mg of leucovorin (equivalent to 10.8 mg of leucovorin calcium), each 15 mg tablet contains 15 mg of leucovorin (equivalent to 16.2 mg of leucovorin calcium) and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium). The 5 mg, 10 mg, 15 mg and 25 mg tablets contain the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Additionally, the 15 mg and 25 mg tablets contains FD&amp;C yellow #6.</Description>
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    <NDCCode>50742-260-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-260-01) </PackageDescription>
    <NDC11Code>50742-0260-01</NDC11Code>
    <ProductNDC>50742-260</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nifedipine</ProprietaryName>
    <NonProprietaryName>Nifedipine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190312</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210614</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>NIFEDIPINE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190312</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.</IndicationAndUsage>
    <Description>Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4- (2-nitrophenyl)-, dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets are formulated as a once-a-day controlled-release tablet for oral administration to provide 30, 60, or 90 mg of nifedipine. Inert ingredients in the nifedipine extended-release tablet formulation are lactose monohydrate, microcrystalline cellulose, hypromellose, hydroxyethyl cellulose, ethylcellulose, sodium lauryl sulfate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, polyethylene glycol, talc, polyvinyl alcohol, titanium dioxide (30mg and 60mg), iron oxide yellow, iron oxide red, lecithin (soya) (30 mg and 90 mg), iron oxide black (30 mg and 90 mg).</Description>
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  <NDC>
    <NDCCode>50742-260-03</NDCCode>
    <PackageDescription>300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-260-03) </PackageDescription>
    <NDC11Code>50742-0260-03</NDC11Code>
    <ProductNDC>50742-260</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <NonProprietaryName>Nifedipine</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190312</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210614</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>NIFEDIPINE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190312</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.</IndicationAndUsage>
    <Description>Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4- (2-nitrophenyl)-, dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets are formulated as a once-a-day controlled-release tablet for oral administration to provide 30, 60, or 90 mg of nifedipine. Inert ingredients in the nifedipine extended-release tablet formulation are lactose monohydrate, microcrystalline cellulose, hypromellose, hydroxyethyl cellulose, ethylcellulose, sodium lauryl sulfate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, polyethylene glycol, talc, polyvinyl alcohol, titanium dioxide (30mg and 60mg), iron oxide yellow, iron oxide red, lecithin (soya) (30 mg and 90 mg), iron oxide black (30 mg and 90 mg).</Description>
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    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-260-30) </PackageDescription>
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    <ProductNDC>50742-260</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nifedipine</ProprietaryName>
    <NonProprietaryName>Nifedipine</NonProprietaryName>
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    <ApplicationNumber>ANDA210614</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>NIFEDIPINE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190312</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.</IndicationAndUsage>
    <Description>Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4- (2-nitrophenyl)-, dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets are formulated as a once-a-day controlled-release tablet for oral administration to provide 30, 60, or 90 mg of nifedipine. Inert ingredients in the nifedipine extended-release tablet formulation are lactose monohydrate, microcrystalline cellulose, hypromellose, hydroxyethyl cellulose, ethylcellulose, sodium lauryl sulfate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, polyethylene glycol, talc, polyvinyl alcohol, titanium dioxide (30mg and 60mg), iron oxide yellow, iron oxide red, lecithin (soya) (30 mg and 90 mg), iron oxide black (30 mg and 90 mg).</Description>
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  <NDC>
    <NDCCode>50742-261-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-261-01) </PackageDescription>
    <NDC11Code>50742-0261-01</NDC11Code>
    <ProductNDC>50742-261</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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    <NonProprietaryName>Nifedipine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190312</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210614</ApplicationNumber>
    <LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>NIFEDIPINE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-10</LastUpdate>
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    <IndicationAndUsage>Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.</IndicationAndUsage>
    <Description>Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4- (2-nitrophenyl)-, dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets are formulated as a once-a-day controlled-release tablet for oral administration to provide 30, 60, or 90 mg of nifedipine. Inert ingredients in the nifedipine extended-release tablet formulation are lactose monohydrate, microcrystalline cellulose, hypromellose, hydroxyethyl cellulose, ethylcellulose, sodium lauryl sulfate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, polyethylene glycol, talc, polyvinyl alcohol, titanium dioxide (30mg and 60mg), iron oxide yellow, iron oxide red, lecithin (soya) (30 mg and 90 mg), iron oxide black (30 mg and 90 mg).</Description>
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