RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>80830-2363-2</NDCCode>
    <PackageDescription>12 POUCH in 1 CARTON (80830-2363-2)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>80830-2363-02</NDC11Code>
    <ProductNDC>80830-2363</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Gluconate</ProprietaryName>
    <NonProprietaryName>Calcium Gluconate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230908</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217174</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcium gluconate in sodium chloride injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of calcium gluconate injection for long term use has not been established.</IndicationAndUsage>
    <Description>Calcium gluconate in sodium chloride injection is a sterile, clear, colorless, preservative-free, nonpyrogenic, solution of calcium gluconate, a form of calcium, for intravenous use. The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O. Molecular weight: 448.39 g/mol. Solubility in water: 3.5 g/100 mL at 25°C. Calcium gluconate monohydrate, USP is a white, crystalline granules or powder. It is soluble in boiling water, sparingly soluble in water and insoluble in alcohol. Calcium Gluconate in Sodium Chloride Injection is available as 1,000 mg per 50 mL (18.8 mg per mL) or 2,000 mg per 100 mL (18.8 mg per mL) filled in single-dose infusion bags. Each mL of calcium gluconate in sodium chloride injection contains 20 mg of calcium gluconate (equivalent to 18.8 mg of calcium gluconate and 0.9 mg of calcium saccharate tetrahydrate), 6.75 mg sodium chloride as tonicity adjustor, hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and water for injection. Each mL of calcium gluconate in sodium chloride injection contains 1.86 mg (0.093 mEq) of elemental calcium.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2363-9</NDCCode>
    <PackageDescription>24 POUCH in 1 CARTON (80830-2363-9)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>80830-2363-09</NDC11Code>
    <ProductNDC>80830-2363</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Gluconate</ProprietaryName>
    <NonProprietaryName>Calcium Gluconate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230908</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217174</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230908</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcium gluconate in sodium chloride injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of calcium gluconate injection for long term use has not been established.</IndicationAndUsage>
    <Description>Calcium gluconate in sodium chloride injection is a sterile, clear, colorless, preservative-free, nonpyrogenic, solution of calcium gluconate, a form of calcium, for intravenous use. The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O. Molecular weight: 448.39 g/mol. Solubility in water: 3.5 g/100 mL at 25°C. Calcium gluconate monohydrate, USP is a white, crystalline granules or powder. It is soluble in boiling water, sparingly soluble in water and insoluble in alcohol. Calcium Gluconate in Sodium Chloride Injection is available as 1,000 mg per 50 mL (18.8 mg per mL) or 2,000 mg per 100 mL (18.8 mg per mL) filled in single-dose infusion bags. Each mL of calcium gluconate in sodium chloride injection contains 20 mg of calcium gluconate (equivalent to 18.8 mg of calcium gluconate and 0.9 mg of calcium saccharate tetrahydrate), 6.75 mg sodium chloride as tonicity adjustor, hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and water for injection. Each mL of calcium gluconate in sodium chloride injection contains 1.86 mg (0.093 mEq) of elemental calcium.</Description>
  </NDC>
  <NDC>
    <NDCCode>15631-2363-2</NDCCode>
    <PackageDescription>50 TABLET in 1 CONTAINER (15631-2363-2)</PackageDescription>
    <NDC11Code>15631-2363-02</NDC11Code>
    <ProductNDC>15631-2363</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bio-combination 8</ProprietaryName>
    <NonProprietaryName>Calcarea Phosphorica, Ferrum Phosphoricum, Kali Phosphoricum, Kali Sulphuricum, Natrum Phosphoricum, Natrum Sulphuricum</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160411</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SODIUM SULFATE</SubstanceName>
    <StrengthNumber>3; 3; 3; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>36987-2363-2</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2363-2)</PackageDescription>
    <NDC11Code>36987-2363-02</NDC11Code>
    <ProductNDC>36987-2363</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Standardized Redtop Grass Pollen</ProprietaryName>
    <NonProprietaryName>Standardized Redtop Grass Pollen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19980210</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>AGROSTIS GIGANTEA POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Standardized Grass Pollen extracts labeled in BAU/mL are not interchangeable with Grass Pollen extracts labeled in AU/mL or with non-standardized Grass Pollen extracts. The 10,000 BAU/mL dose form is indicated for percutaneous testing. If negative, 100,000 BAU/mL dose form can be used for percutaneous testing. For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage &amp; Administration). The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient. Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed. For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages. If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.</IndicationAndUsage>
    <Description>Standardized Grass Pollen Extracts include: Orchard (Dactylis glomerata), Perennial Rye (Lolium perenne), Timothy (Phleum pratense), Redtop (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda (Cynodon dactylon), Meadow Fescue (Festuca elatior), Sweet Vernal (Anthoxanthum odoratum). The standardized grass pollen extract is prepared by extracting raw pollen material at a ratio of either 1:5 w/v, 1:6.66 w/v or 1:10 w/v in Cocas fluid containing 0.5% NaCl, 0.275% NaHCO3, WFI and 0.4% phenol as preservative. Following extraction, a calculated amount of glycerin is added to make a 50%(v/v) glycerinated solution. Standardized Grass Pollen extracts have potency designations of 10,000 BAU/mL and 100,000 BAU/mL except Bermuda Grass (10,000 BAU/mL only). Extracts with a potency of 10,000 BAU/mL are diluted from the 100,000 BAU/mL lots with Glycerol Saline 50%(v/v). The Glycerol Saline 50%(v/v) solution consists of Glycerin and Salts and Buffered Diluent whose ingredients are 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI and 0.4% phenol as a preservative. All extracts are aseptically filled in sterile containers. Standardized pollen extracts are intended for administration by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injection. Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or with non-standardized grass pollen extracts. The Bioequivalent Allergy Unit (BAU), the potency unit used for all Standardized Pollen Extracts, replaces the previous unitage for these products. Bioequivalent Allergy Units were assigned to the FDA, Center for Biologics Evaluation and Research (CBER) reference extracts, based on quantitative intradermal skin test results. BAU's are intended to assure that the labeled unitage of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted one half million fold to produce an intradermal sum of erythema diameter response of 50mm in highly puncture reactive subjects. 100,000 BAU/mL can be diluted 1:5 million fold to yield the same intradermal response.(2) The assignment of BAU/mL to standardized grass pollen extracts, is accomplished by an ELISA assay comparing the extract to the CBER reference. Previously, the potency / concentration of grass mixtures was designated based on the manufacturing strength, e.g. 1:10 w/v or 1:20 w/v, or in PNU's/mL. For grass mixtures containing standardized extracts, the potency will reflect the contribution of each individual component in the mixture, i.e., the actual potency of each component will be listed on a per mL basis. In addition, because the individual components may be cross-reactive, an additional caution statement, "due to cross reactivity, total potency may be 100,000 BAU/mL," will be added to the label.</Description>
  </NDC>
  <NDC>
    <NDCCode>37662-2363-2</NDCCode>
    <PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-2363-2) </PackageDescription>
    <NDC11Code>37662-2363-02</NDC11Code>
    <ProductNDC>37662-2363</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acidum Picricum</ProprietaryName>
    <NonProprietaryName>Acidum Picricum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230112</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>PICRIC ACID</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>[hp_M]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70518-2363-2</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2363-2) </PackageDescription>
    <NDC11Code>70518-2363-02</NDC11Code>
    <ProductNDC>70518-2363</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Finasteride</ProprietaryName>
    <NonProprietaryName>Finasteride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191016</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090121</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>FINASTERIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210226</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Finasteride, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1): : 1 Improve symptoms, 2 Reduce the risk of acute urinary retention, 3 Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.</IndicationAndUsage>
    <Description>Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17ß)-. The empirical formula of finasteride is C 23H 36N 2O 2and its molecular weight is 372.55. Its structural formula is:. Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets, USP for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, hypromellose, titanium dioxide, magnesium stearate, lauryl macrogolglycerides, FD&amp;C Blue # 2 aluminum lake and polyethylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-2363-2</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (71335-2363-2) </PackageDescription>
    <NDC11Code>71335-2363-02</NDC11Code>
    <ProductNDC>71335-2363</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tadalafil</ProprietaryName>
    <NonProprietaryName>Tadalafil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210609</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>TADALAFIL</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1  erectile dysfunction (ED) (1.1), 2  the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3  ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
    <Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, iron oxide yellow, iron oxide red, ferrosoferric oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, polyvinyl alcohol-partially hydrolyzed, macrogol/PEG 3350 and lecithin (soya).</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-1659-2</NDCCode>
    <PackageDescription>25 VIAL, GLASS in 1 CARTON (80830-1659-2)  / 1 mL in 1 VIAL, GLASS (80830-1659-1) </PackageDescription>
    <NDC11Code>80830-1659-02</NDC11Code>
    <ProductNDC>80830-1659</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Epinephrine</ProprietaryName>
    <NonProprietaryName>Epinephrine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20251208</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218208</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>EPINEPHRINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Epinephrine is a non-selective alpha and beta adrenergic agonist indicated for: 1 Emergency treatment of allergic reactions (Type 1), including anaphylaxis. (1.1), 2 To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. (1.2).</IndicationAndUsage>
    <Description>Epinephrine Injection, USP is a clear, colorless, sterile solution containing 1 mg/mL epinephrine USP, packaged as 1 mL of solution in a single-dose clear glass vial. In the 1 mL vial, each 1 mL of epinephrine injection, USP solution contains 1 mg epinephrine, USP; 9 mg sodium chloride; 1 mg sodium metabisulfite; hydrochloric acid to adjust pH and water for injection. The pH range is 2.2 to 5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-,(R)- or (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol. Its chemical structure is. The molecular weight of epinephrine is 183.2 g/mol and molecular formula is C9H13NO3. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-1672-2</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (80830-1672-2)  / 10 mL in 1 VIAL (80830-1672-1) </PackageDescription>
    <NDC11Code>80830-1672-02</NDC11Code>
    <ProductNDC>80830-1672</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Gluconate</ProprietaryName>
    <NonProprietaryName>Calcium Gluconate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216611</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
    <StrengthNumber>98</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of calcium gluconate injection for long term use has not been established.</IndicationAndUsage>
    <Description>Calcium gluconate injection USP, 100 mg per mL is a sterile, clear, colorless to slightly yellow, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14H2O. Molecular weight: 448.39 g/mol. Solubility in water: 3.5 g/100 mL at 25°C. Calcium gluconate monohydrate, USP is a white, crystalline granules or powder. It is soluble in boiling water, sparingly soluble in water and insoluble in alcohol. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of calcium gluconate injection, USP contains: 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial agent. Each mL of calcium gluconate injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-1673-2</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (80830-1673-2)  / 50 mL in 1 VIAL (80830-1673-1) </PackageDescription>
    <NDC11Code>80830-1673-02</NDC11Code>
    <ProductNDC>80830-1673</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Gluconate</ProprietaryName>
    <NonProprietaryName>Calcium Gluconate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216611</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
    <StrengthNumber>98</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of calcium gluconate injection for long term use has not been established.</IndicationAndUsage>
    <Description>Calcium gluconate injection USP, 100 mg per mL is a sterile, clear, colorless to slightly yellow, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14H2O. Molecular weight: 448.39 g/mol. Solubility in water: 3.5 g/100 mL at 25°C. Calcium gluconate monohydrate, USP is a white, crystalline granules or powder. It is soluble in boiling water, sparingly soluble in water and insoluble in alcohol. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of calcium gluconate injection, USP contains: 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial agent. Each mL of calcium gluconate injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-1674-2</NDCCode>
    <PackageDescription>10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-1674-2)  / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-1674-8) </PackageDescription>
    <NDC11Code>80830-1674-02</NDC11Code>
    <ProductNDC>80830-1674</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Gluconate</ProprietaryName>
    <NonProprietaryName>Calcium Gluconate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20240513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216611</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
    <StrengthNumber>98</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcium gluconate injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of calcium gluconate injection for long term use has not been established.</IndicationAndUsage>
    <Description>Calcium gluconate injection USP, 100 mg per mL is a sterile, clear, colorless to slightly yellow, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14H2O. Molecular weight: 448.39 g/mol. Solubility in water: 3.5 g/100 mL at 25°C. Calcium gluconate monohydrate, USP is a white, crystalline granules or powder. It is soluble in boiling water, sparingly soluble in water and insoluble in alcohol. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of calcium gluconate injection, USP contains: 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial agent. Each mL of calcium gluconate injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-1683-3</NDCCode>
    <PackageDescription>5 TRAY in 1 CARTON (80830-1683-3)  / 5 VIAL, GLASS in 1 TRAY (80830-1683-2)  / 1 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>80830-1683-03</NDC11Code>
    <ProductNDC>80830-1683</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phytonadione</ProprietaryName>
    <NonProprietaryName>Phytonadione</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20260601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217734</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>PHYTONADIONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phytonadione injectable emulsion is a vitamin K replacement indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives. (1.1), 2 Hypoprothrombinemia due to antibacterial therapy. (1.1), 3 Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis. (1.1), 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. (1.1).</IndicationAndUsage>
    <Description>Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, very viscous liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and in vegetable oils; slightly soluble in alcohol and insoluble in water. It has a molecular weight of 450.70 g/mol. Phytonadione is 2-Methyl-3-(3,7,11,15-tetramethylhexadec-2-en-1-yl)naphthalene-1,4-dione. It’s molecular formula is C31H46O2 and its molecular structure is. Phytonadione injectable emulsion, USP is a clear, yellow color, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Phytonadione injectable emulsion, USP is available in 10 mg (10 mg/mL) single-dose vial. Each milliliter contains phytonadione USP, 10 mg; polyoxyethylated fatty acid derivative 70 mg; citric acid monohydrate 1 mg; disodium hydrogen phosphate dihydrate 3 mg and dextrose, hydrous 37.5 mg in water for injection. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-1691-2</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (80830-1691-2)  / 15 mL in 1 VIAL, SINGLE-DOSE (80830-1691-1) </PackageDescription>
    <NDC11Code>80830-1691-02</NDC11Code>
    <ProductNDC>80830-1691</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Phosphates</ProprietaryName>
    <NonProprietaryName>Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,</NonProprietaryName>
    <DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20231023</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216344</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC</SubstanceName>
    <StrengthNumber>224; 236</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231023</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium phosphates injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .</IndicationAndUsage>
    <Description>Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate. The molecular formula is KH2PO4, molecular weight is 136.084 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water and practically insoluble in alcohol. Dibasic potassium phosphate, USP is chemically designated dipotassium hydrogen phosphate. The molecular formula is K2HPO4, molecular weight is 174.18 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water. Each mL of Potassium Phosphates Injection, USP contains monobasic potassium phosphate USP, 224 mg; dibasic potassium phosphate USP, 236 mg and water for injection. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-1692-2</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (80830-1692-2)  / 50 mL in 1 VIAL (80830-1692-1) </PackageDescription>
    <NDC11Code>80830-1692-02</NDC11Code>
    <ProductNDC>80830-1692</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Phosphates</ProprietaryName>
    <NonProprietaryName>Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,</NonProprietaryName>
    <DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20231023</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216344</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC</SubstanceName>
    <StrengthNumber>224; 236</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-01-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231023</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium phosphates injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .</IndicationAndUsage>
    <Description>Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate. The molecular formula is KH2PO4, molecular weight is 136.084 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water and practically insoluble in alcohol. Dibasic potassium phosphate, USP is chemically designated dipotassium hydrogen phosphate. The molecular formula is K2HPO4, molecular weight is 174.18 g/mol and the structural formula is as below. It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water. Each mL of Potassium Phosphates Injection, USP contains monobasic potassium phosphate USP, 224 mg; dibasic potassium phosphate USP, 236 mg and water for injection. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2305-2</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (80830-2305-2)  / 50 mL in 1 VIAL, SINGLE-DOSE (80830-2305-1) </PackageDescription>
    <NDC11Code>80830-2305-02</NDC11Code>
    <ProductNDC>80830-2305</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Bicarbonate</ProprietaryName>
    <NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217523</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>84</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Alkalinizing Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium bicarbonate injection is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis - e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial - e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.</IndicationAndUsage>
    <Description>Sodium bicarbonate injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection, the approximate pH of the solution is between 7.0 to 8.5. When smaller doses are required, the unused portion should be discarded. Sodium bicarbonate USP, 84 mg is equal to one milliequivalent each of Na+ and HCO3-. Sodium bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water and insoluble in ethanol. Water for injection, USP is chemically designated H2O.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2329-2</NDCCode>
    <PackageDescription>10 POUCH in 1 CARTON (80830-2329-2)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>80830-2329-02</NDC11Code>
    <ProductNDC>80830-2329</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tranexamic Acid In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Tranexamic Acid</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20231023</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217155</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>TRANEXAMIC ACID</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231023</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tranexamic acid in 0.7% sodium chloride injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
    <Description>Tranexamic acid, USP is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white, crystalline powder. The structural formula is. Molecular Formula: C8H15NO2                                             Molecular Weight: 157.21 g/mol. Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg per mL) is a sterile, clear, colorless, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains: 1,000 mg of tranexamic acid, USP; 700 mg of sodium chloride, USP and water for injection, USP. The aqueous solution has a pH of 6.5 to 8.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2362-2</NDCCode>
    <PackageDescription>12 POUCH in 1 CARTON (80830-2362-2)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>80830-2362-02</NDC11Code>
    <ProductNDC>80830-2362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Calcium Gluconate</ProprietaryName>
    <NonProprietaryName>Calcium Gluconate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230908</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217174</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>CALCIUM GLUCONATE MONOHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Calcium gluconate in sodium chloride injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use. The safety of calcium gluconate injection for long term use has not been established.</IndicationAndUsage>
    <Description>Calcium gluconate in sodium chloride injection is a sterile, clear, colorless, preservative-free, nonpyrogenic, solution of calcium gluconate, a form of calcium, for intravenous use. The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is. Molecular formula: C12H22CaO14 H2O. Molecular weight: 448.39 g/mol. Solubility in water: 3.5 g/100 mL at 25°C. Calcium gluconate monohydrate, USP is a white, crystalline granules or powder. It is soluble in boiling water, sparingly soluble in water and insoluble in alcohol. Calcium Gluconate in Sodium Chloride Injection is available as 1,000 mg per 50 mL (18.8 mg per mL) or 2,000 mg per 100 mL (18.8 mg per mL) filled in single-dose infusion bags. Each mL of calcium gluconate in sodium chloride injection contains 20 mg of calcium gluconate (equivalent to 18.8 mg of calcium gluconate and 0.9 mg of calcium saccharate tetrahydrate), 6.75 mg sodium chloride as tonicity adjustor, hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and water for injection. Each mL of calcium gluconate in sodium chloride injection contains 1.86 mg (0.093 mEq) of elemental calcium.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2435-2</NDCCode>
    <PackageDescription>25 BOTTLE, PLASTIC in 1 CARTON (80830-2435-2)  / 20 mL in 1 BOTTLE, PLASTIC (80830-2435-1) </PackageDescription>
    <NDC11Code>80830-2435-02</NDC11Code>
    <ProductNDC>80830-2435</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Acetate</ProprietaryName>
    <NonProprietaryName>Sodium Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260303</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218469</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>SODIUM ACETATE ANHYDROUS</SubstanceName>
    <StrengthNumber>164</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260303</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium acetate injection, 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.</IndicationAndUsage>
    <Description>Sodium acetate injection USP, 40 mEq (2 mEq/mL) is a sterile, clear, colorless, nonpyrogenic, concentrated solution of sodium acetate in water for injection. The solution is administered, after dilution, by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each 20 mL contains 3.28 g of sodium acetate, USP (anhydrous) which provides 40 mEq each of sodium (Na+) and acetate (CH3COO−). The solution contains no bacteriostat, antimicrobial agent or added buffer. May contain acetic acid for pH adjustment; the pH is 6.0 to 7.0. The osmolar concentration is 4 mOsmol/mL (calc). The solution is intended as an alternative to sodium chloride to provide sodium ion (Na+) for addition to large volume infusion fluids for intravenous use. Sodium acetate, USP (anhydrous) is chemically designated CH3COONa, a hygroscopic powder freely soluble in water.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2436-2</NDCCode>
    <PackageDescription>25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2436-2)  / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2436-1) </PackageDescription>
    <NDC11Code>80830-2436-02</NDC11Code>
    <ProductNDC>80830-2436</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Acetate</ProprietaryName>
    <NonProprietaryName>Sodium Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250812</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218469</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>SODIUM ACETATE ANHYDROUS</SubstanceName>
    <StrengthNumber>164</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium acetate injection, 2 mEq/mL is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.</IndicationAndUsage>
    <Description>Sodium acetate injection, USP (2 mEq/mL) is a sterile, clear, colorless, nonpyrogenic, concentrated solution of sodium acetate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 164 mg of sodium acetate, USP (anhydrous) which provides 2 mEq each of sodium (Na+) and acetate (CH3COO-). The solution contains no bacteriostat, antimicrobial agent or added buffer. May contain acetic acid for pH adjustment; the pH is 6.5 (6.0 to 7.0). The osmolar concentration is 4 mOsmol/mL (calc.); specific gravity 1.081. The solution is intended as an alternative to sodium chloride to provide sodium ion (Na+) for addition to large volume infusion fluids for intravenous use. Sodium acetate, USP, anhydrous is chemically designated CH3COONa, a hygroscopic powder freely soluble in water. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2437-2</NDCCode>
    <PackageDescription>10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2437-2)  / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2437-1) </PackageDescription>
    <NDC11Code>80830-2437-02</NDC11Code>
    <ProductNDC>80830-2437</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Acetate</ProprietaryName>
    <NonProprietaryName>Sodium Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250812</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218469</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>SODIUM ACETATE ANHYDROUS</SubstanceName>
    <StrengthNumber>164</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium acetate injection, 2 mEq/mL is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.</IndicationAndUsage>
    <Description>Sodium acetate injection, USP (2 mEq/mL) is a sterile, clear, colorless, nonpyrogenic, concentrated solution of sodium acetate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 164 mg of sodium acetate, USP (anhydrous) which provides 2 mEq each of sodium (Na+) and acetate (CH3COO-). The solution contains no bacteriostat, antimicrobial agent or added buffer. May contain acetic acid for pH adjustment; the pH is 6.5 (6.0 to 7.0). The osmolar concentration is 4 mOsmol/mL (calc.); specific gravity 1.081. The solution is intended as an alternative to sodium chloride to provide sodium ion (Na+) for addition to large volume infusion fluids for intravenous use. Sodium acetate, USP, anhydrous is chemically designated CH3COONa, a hygroscopic powder freely soluble in water. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2466-2</NDCCode>
    <PackageDescription>10 BOTTLE, PLASTIC in 1 CARTON (80830-2466-2)  / 50 mL in 1 BOTTLE, PLASTIC (80830-2466-1) </PackageDescription>
    <NDC11Code>80830-2466-02</NDC11Code>
    <ProductNDC>80830-2466</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iohexol</ProprietaryName>
    <NonProprietaryName>Iohexol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL</RouteName>
    <StartMarketingDate>20260625</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217737</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>IOHEXOL</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity imaging procedures in adults and pediatric patients. (1).</IndicationAndUsage>
    <Description>Iohexol, USP is a nonionic radiographic contrast agent available as: 1 Iohexol injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity use.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2467-2</NDCCode>
    <PackageDescription>10 BOTTLE, PLASTIC in 1 CARTON (80830-2467-2)  / 75 mL in 1 BOTTLE, PLASTIC (80830-2467-1) </PackageDescription>
    <NDC11Code>80830-2467-02</NDC11Code>
    <ProductNDC>80830-2467</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iohexol</ProprietaryName>
    <NonProprietaryName>Iohexol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL</RouteName>
    <StartMarketingDate>20251113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217737</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>IOHEXOL</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity imaging procedures in adults and pediatric patients. (1).</IndicationAndUsage>
    <Description>Iohexol, USP is a nonionic radiographic contrast agent available as: 1 Iohexol injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity use.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2468-2</NDCCode>
    <PackageDescription>10 BOTTLE, PLASTIC in 1 CARTON (80830-2468-2)  / 100 mL in 1 BOTTLE, PLASTIC (80830-2468-1) </PackageDescription>
    <NDC11Code>80830-2468-02</NDC11Code>
    <ProductNDC>80830-2468</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iohexol</ProprietaryName>
    <NonProprietaryName>Iohexol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL</RouteName>
    <StartMarketingDate>20251113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217737</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>IOHEXOL</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity imaging procedures in adults and pediatric patients. (1).</IndicationAndUsage>
    <Description>Iohexol, USP is a nonionic radiographic contrast agent available as: 1 Iohexol injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity use.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2471-2</NDCCode>
    <PackageDescription>10 BOTTLE, PLASTIC in 1 CARTON (80830-2471-2)  / 50 mL in 1 BOTTLE, PLASTIC (80830-2471-1) </PackageDescription>
    <NDC11Code>80830-2471-02</NDC11Code>
    <ProductNDC>80830-2471</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iohexol</ProprietaryName>
    <NonProprietaryName>Iohexol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL</RouteName>
    <StartMarketingDate>20260625</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217737</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>IOHEXOL</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity imaging procedures in adults and pediatric patients. (1).</IndicationAndUsage>
    <Description>Iohexol, USP is a nonionic radiographic contrast agent available as: 1 Iohexol injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity use.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2472-2</NDCCode>
    <PackageDescription>10 BOTTLE, PLASTIC in 1 CARTON (80830-2472-2)  / 75 mL in 1 BOTTLE, PLASTIC (80830-2472-1) </PackageDescription>
    <NDC11Code>80830-2472-02</NDC11Code>
    <ProductNDC>80830-2472</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iohexol</ProprietaryName>
    <NonProprietaryName>Iohexol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL</RouteName>
    <StartMarketingDate>20260625</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217737</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>IOHEXOL</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity imaging procedures in adults and pediatric patients. (1).</IndicationAndUsage>
    <Description>Iohexol, USP is a nonionic radiographic contrast agent available as: 1 Iohexol injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity use.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2473-2</NDCCode>
    <PackageDescription>10 BOTTLE, PLASTIC in 1 CARTON (80830-2473-2)  / 100 mL in 1 BOTTLE, PLASTIC (80830-2473-1) </PackageDescription>
    <NDC11Code>80830-2473-02</NDC11Code>
    <ProductNDC>80830-2473</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iohexol</ProprietaryName>
    <NonProprietaryName>Iohexol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL</RouteName>
    <StartMarketingDate>20260625</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217737</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>IOHEXOL</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity imaging procedures in adults and pediatric patients. (1).</IndicationAndUsage>
    <Description>Iohexol, USP is a nonionic radiographic contrast agent available as: 1 Iohexol injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity use.</Description>
  </NDC>
  <NDC>
    <NDCCode>80830-2613-2</NDCCode>
    <PackageDescription>6 POUCH in 1 CARTON (80830-2613-2)  / 1 BAG in 1 POUCH (80830-2613-1)  / 1000 mL in 1 BAG</PackageDescription>
    <NDC11Code>80830-2613-02</NDC11Code>
    <ProductNDC>80830-2613</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sodium Bicarbonate</ProprietaryName>
    <NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260713</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA220790</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>SODIUM BICARBONATE</SubstanceName>
    <StrengthNumber>12.6</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Alkalinizing Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260713</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sodium bicarbonate injection is an alkalinizing agent indicated: 1 to raise plasma pH in adults and pediatric patients with clinically significant metabolic acidosis. (1.1) , 2 to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion. (1.2).</IndicationAndUsage>
    <Description>Sodium bicarbonate injection, USP is an alkalinizing agent, supplied as a sterile, nonpyrogenic, clear, colorless, ready-to-use solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous infusion as an electrolyte replenisher and systemic alkalizer. Sodium bicarbonate, 12.6 mg is equal to 0.15 milliequivalent each of Na+ and HCO3-. Sodium bicarbonate, USP is chemically designated NaHCO3, molecular weight 84.01 g/mol, a white crystalline powder soluble in water and insoluble in ethanol. Solution is offered in concentration of 1.26% [see How Supplied Storage and Handling (16.1)]. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as an intravenous infusion. Carbon dioxide is added to adjust pH between 7 to 8.5. When smaller doses are required, the unused portion should be discarded.</Description>
  </NDC>
  <NDC>
    <NDCCode>0591-2363-60</NDCCode>
    <PackageDescription>1 CANISTER in 1 CARTON (0591-2363-60)  / 60 g in 1 CANISTER</PackageDescription>
    <NDC11Code>00591-2363-60</NDC11Code>
    <ProductNDC>0591-2363</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Testosterone</ProprietaryName>
    <NonProprietaryName>Testosterone</NonProprietaryName>
    <DosageFormName>GEL, METERED</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150601</StartMarketingDate>
    <EndMarketingDate>20260131</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204571</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>TESTOSTERONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/.5g</StrengthUnit>
    <Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Testosterone gel is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: : 1 Primary hypogonadism (congenital or acquired) – testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol, heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone [FSH] and luteinizing hormone [LH]) above the normal range. , 2 Hypogonadotropic hypogonadism (congenital or acquired) – gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations but have gonadotropins in the normal or low range. .</IndicationAndUsage>
    <Description>Testosterone gel is a clear, colorless, odorless, gel containing testosterone, USP. Testosterone gel is available in a metered-dose pump. Each pump actuation provides 10 mg of testosterone, USP and each container is capable of dispensing 120 pump actuations. One (1) pump actuation dispenses 0.5 g of gel. The active pharmacologic ingredient in testosterone gel is testosterone, USP. Testosterone, USP is a white to almost white powder described chemically as 17-beta hydroxyandrost-4-en-3-one. Pharmacologically inactive ingredients in testosterone gel are: butylated hydroxytoluene, carbomer 1382, dehydrated alcohol, isopropyl alcohol, oleic acid, propylene glycol, purified water, and trolamine.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2363-01</NDCCode>
    <PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2363-01) </PackageDescription>
    <NDC11Code>00781-2363-01</NDC11Code>
    <ProductNDC>0781-2363</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylphenidate</ProprietaryName>
    <NonProprietaryName>Methylphenidate</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151124</StartMarketingDate>
    <EndMarketingDate>20270430</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA021284</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20151124</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)]. Limitations of Use. The use of methylphenidate hydrochloride extended release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
    <Description>Methylphenidate hydrochloride extended-release capsules are CNS stimulant. Methylphenidate hydrochloride extended-release capsules is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in methylphenidate hydrochloride extended-release capsules is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, black iron oxide (10 and 40 mg capsules only), gelatin, methacrylic acid copolymer, polyethylene glycol, red iron oxide (10 and 40 mg capsules only), sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide (10, 30, and 40 mg capsules only).</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-2363-1</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-2363-1)</PackageDescription>
    <NDC11Code>36987-2363-01</NDC11Code>
    <ProductNDC>36987-2363</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Standardized Redtop Grass Pollen</ProprietaryName>
    <NonProprietaryName>Standardized Redtop Grass Pollen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19980210</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>AGROSTIS GIGANTEA POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Standardized Grass Pollen extracts labeled in BAU/mL are not interchangeable with Grass Pollen extracts labeled in AU/mL or with non-standardized Grass Pollen extracts. The 10,000 BAU/mL dose form is indicated for percutaneous testing. If negative, 100,000 BAU/mL dose form can be used for percutaneous testing. For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage &amp; Administration). The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient. Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed. For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages. If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.</IndicationAndUsage>
    <Description>Standardized Grass Pollen Extracts include: Orchard (Dactylis glomerata), Perennial Rye (Lolium perenne), Timothy (Phleum pratense), Redtop (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda (Cynodon dactylon), Meadow Fescue (Festuca elatior), Sweet Vernal (Anthoxanthum odoratum). The standardized grass pollen extract is prepared by extracting raw pollen material at a ratio of either 1:5 w/v, 1:6.66 w/v or 1:10 w/v in Cocas fluid containing 0.5% NaCl, 0.275% NaHCO3, WFI and 0.4% phenol as preservative. Following extraction, a calculated amount of glycerin is added to make a 50%(v/v) glycerinated solution. Standardized Grass Pollen extracts have potency designations of 10,000 BAU/mL and 100,000 BAU/mL except Bermuda Grass (10,000 BAU/mL only). Extracts with a potency of 10,000 BAU/mL are diluted from the 100,000 BAU/mL lots with Glycerol Saline 50%(v/v). The Glycerol Saline 50%(v/v) solution consists of Glycerin and Salts and Buffered Diluent whose ingredients are 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI and 0.4% phenol as a preservative. All extracts are aseptically filled in sterile containers. Standardized pollen extracts are intended for administration by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injection. Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or with non-standardized grass pollen extracts. The Bioequivalent Allergy Unit (BAU), the potency unit used for all Standardized Pollen Extracts, replaces the previous unitage for these products. Bioequivalent Allergy Units were assigned to the FDA, Center for Biologics Evaluation and Research (CBER) reference extracts, based on quantitative intradermal skin test results. BAU's are intended to assure that the labeled unitage of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted one half million fold to produce an intradermal sum of erythema diameter response of 50mm in highly puncture reactive subjects. 100,000 BAU/mL can be diluted 1:5 million fold to yield the same intradermal response.(2) The assignment of BAU/mL to standardized grass pollen extracts, is accomplished by an ELISA assay comparing the extract to the CBER reference. Previously, the potency / concentration of grass mixtures was designated based on the manufacturing strength, e.g. 1:10 w/v or 1:20 w/v, or in PNU's/mL. For grass mixtures containing standardized extracts, the potency will reflect the contribution of each individual component in the mixture, i.e., the actual potency of each component will be listed on a per mL basis. In addition, because the individual components may be cross-reactive, an additional caution statement, "due to cross reactivity, total potency may be 100,000 BAU/mL," will be added to the label.</Description>
  </NDC>
</NDCList>