{
"NDC": [
{
"NDCCode": "59651-960-47",
"PackageDescription": "473 mL in 1 BOTTLE (59651-960-47) ",
"NDC11Code": "59651-0960-47",
"ProductNDC": "59651-960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20251120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216536",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "meq/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251120",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium Chloride, USP is a white crystalline powder or colourless crystals. It is freely soluble in water, practically insoluble in ethanol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor (contains dl-alpha-Tocopherol), propylene glycol, propylparaben, purified water, sodium citrate and sucralose. Oral Solution 20%: Each 15 mL of solution contains 3 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor (contains dl-alpha-Tocopherol), propylene glycol, propylparaben, purified water, sodium citrate and sucralose."
},
{
"NDCCode": "59651-032-47",
"PackageDescription": "1 BOTTLE in 1 CARTON (59651-032-47) / 473 mL in 1 BOTTLE",
"NDC11Code": "59651-0032-47",
"ProductNDC": "59651-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen Oral",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209178",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180518",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen oral suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). In Pediatric Patients, Ibuprofen Oral Suspension is indicated: 1 For reduction of fever in patients aged 6 months up to 2 years of age., 2 For relief of mild to moderate pain in patients aged 6 months up to 2 years of age. , 3 For relief of signs and symptoms of juvenile arthritis. .",
"Description": "The active ingredient in Ibuprofen oral suspension USP is ibuprofen, which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to off-white crystalline powder, with a melting point of 75° to 78°C. It is practically insoluble in water (< 0.1 mg/mL), but very soluble in alcohol, methanol, chloroform and acetone, slightly soluble in ethyl acetate. Ibuprofen has a pKa of 3.6 and an n-octanol/water partition coefficient of 3.3. The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid. The molecular weight of ibuprofen is 206.28. Its molecular formula is C13H18O2 and it has the following structural formula: Ibuprofen oral suspension USP is a light orange to orange colored, berry flavored suspension containing 100 mg of ibuprofen USP in 5 mL (20 mg/mL). Inactive ingredients include: acesulfame potassium, art raspberry, citric acid anhydrous, D&C yellow No. 10, FD & C red No.40, glycerin, hypromellose, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose and xanthan gum."
},
{
"NDCCode": "59651-435-47",
"PackageDescription": "1 BOTTLE in 1 CARTON (59651-435-47) / 473 mL in 1 BOTTLE",
"NDC11Code": "59651-0435-47",
"ProductNDC": "59651-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214847",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate oral solution is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).",
"Description": "Glycopyrrolate is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate USP per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-,bromide. The chemical structure is. The molecular formula for glycopyrrolate is C19H28BrNO3 and the molecular weight is 398.33. The inactive ingredients in glycopyrrolate oral solution are: citric acid monohydrate, glycerin, methylparaben, N&A strawberry FL Wild, non crystallizing sorbitol solution, propylene glycol, propylparaben, purified water, saccharin sodium and sodium citrate (dihydrate)."
},
{
"NDCCode": "59651-493-47",
"PackageDescription": "473 mL in 1 BOTTLE (59651-493-47) ",
"NDC11Code": "59651-0493-47",
"ProductNDC": "59651-493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216331",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2025-12-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220331",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections: Acyclovir oral suspension is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir oral suspension is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir oral suspension is indicated for the treatment of chickenpox (varicella).",
"Description": "PRESCRIBING INFORMATION DESCRIPTION Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir oral suspension, USP is a formulation for oral administration. Each teaspoonful (5 mL) of acyclovir oral suspension, USP contains 200 mg of acyclovir USP and the inactive ingredients: banana flavor, carboxymethylcellulose sodium, glycerin, methylparaben 0.1% (added as preservative), microcrystalline cellulose and carboxymethylcellulose sodium, noncrystallizing sorbitol solution, propylene glycol, propylparaben 0.02% (added as preservative), and purified water. Acyclovir, USP is a white or almost white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 1.513 mg/mL. The pka of acyclovir is 9.67. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action: Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy."
},
{
"NDCCode": "59651-528-47",
"PackageDescription": "1 BOTTLE in 1 CARTON (59651-528-47) / 473 mL in 1 BOTTLE",
"NDC11Code": "59651-0528-47",
"ProductNDC": "59651-528",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20251003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216504",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251003",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen oral suspension is indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis , 2 osteoarthritis , 3 ankylosing spondylitis , 4 polyarticular juvenile idiopathic arthritis , 5 tendonitis , 6 bursitis , 7 acute gout .",
"Description": "Naproxen oral suspension, USP is available as a light orange-colored, pineapple-orange flavored homogenous suspension containing 125 mg/5 mL of naproxen USP for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. The molecular weight is 230.26. Its molecular formula is C14H14O3, and it has the following chemical structure. Naproxen USP is a white to off-white crystalline powder. It is soluble in chloroform, in dehydrated alcohol, and in alcohol, sparingly soluble in ether, practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen oral suspension USP include art pineapple flavor, benzyl alcohol, FD&C yellow No. 6, fumaric acid, magnesium aluminum silicate, methylparaben, modified food starch (corn), nat orange flavor, noncrystallizing sorbitol solution, propylene glycol, purified water, sodium chloride (39 mg/5 mL, 0.667 mEq), sucrose, and xanthan gum. The pH of the suspension ranges from 2.2 to 3.7."
},
{
"NDCCode": "59651-687-47",
"PackageDescription": "115000 TABLET in 1 BAG (59651-687-47) ",
"NDC11Code": "59651-0687-47",
"ProductNDC": "59651-687",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Fluphenazine Hydrochloride",
"DosageFormName": "TABLET",
"StartMarketingDate": "20230818",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FLUPHENAZINE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2023-08-25",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "18-AUG-23"
},
{
"NDCCode": "59651-959-47",
"PackageDescription": "473 mL in 1 BOTTLE (59651-959-47) ",
"NDC11Code": "59651-0959-47",
"ProductNDC": "59651-959",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20251120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216536",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "meq/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251120",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium Chloride, USP is a white crystalline powder or colourless crystals. It is freely soluble in water, practically insoluble in ethanol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor (contains dl-alpha-Tocopherol), propylene glycol, propylparaben, purified water, sodium citrate and sucralose. Oral Solution 20%: Each 15 mL of solution contains 3 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor (contains dl-alpha-Tocopherol), propylene glycol, propylparaben, purified water, sodium citrate and sucralose."
},
{
"NDCCode": "59651-152-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (59651-152-01) ",
"NDC11Code": "59651-0152-01",
"ProductNDC": "59651-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Progesterone",
"NonProprietaryName": "Progesterone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211285",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181026",
"SamplePackage": "N",
"IndicationAndUsage": "Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.",
"Description": "Progesterone capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, crystalline powder or colorless crystals practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, melting between 126º and 131ºC. The structural formula is. Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain 100 mg or 200 mg micronized progesterone USP. The inactive ingredients for progesterone capsules include: gelatin, glycerin, hypromellose, iron oxide black, lecithin, peanut oil, propylene glycol, titanium dioxide."
},
{
"NDCCode": "59651-153-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (59651-153-01) ",
"NDC11Code": "59651-0153-01",
"ProductNDC": "59651-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Progesterone",
"NonProprietaryName": "Progesterone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211285",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181026",
"SamplePackage": "N",
"IndicationAndUsage": "Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.",
"Description": "Progesterone capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, crystalline powder or colorless crystals practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, melting between 126º and 131ºC. The structural formula is. Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain 100 mg or 200 mg micronized progesterone USP. The inactive ingredients for progesterone capsules include: gelatin, glycerin, hypromellose, iron oxide black, lecithin, peanut oil, propylene glycol, titanium dioxide."
},
{
"NDCCode": "59651-638-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (59651-638-01) ",
"NDC11Code": "59651-0638-01",
"ProductNDC": "59651-638",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolate Mofetil",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217937",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240220",
"SamplePackage": "N",
"IndicationAndUsage": "Mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. Mycophenolate mofetil USP is a white or almost white crystalline powder. It is practically insoluble in water, freely soluble in acetone, sparingly soluble in anhydrous ethanol. The partition coefficient is 3.47. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil USP is available for oral administration as tablets containing 500 mg of mycophenolate mofetil USP. Inactive ingredients in mycophenolate mofetil tablets USP, 500 mg include colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "59651-638-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (59651-638-05) ",
"NDC11Code": "59651-0638-05",
"ProductNDC": "59651-638",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolate Mofetil",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217937",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240220",
"SamplePackage": "N",
"IndicationAndUsage": "Mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. Mycophenolate mofetil USP is a white or almost white crystalline powder. It is practically insoluble in water, freely soluble in acetone, sparingly soluble in anhydrous ethanol. The partition coefficient is 3.47. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil USP is available for oral administration as tablets containing 500 mg of mycophenolate mofetil USP. Inactive ingredients in mycophenolate mofetil tablets USP, 500 mg include colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "59651-646-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (59651-646-26) / 225 mL in 1 BOTTLE",
"NDC11Code": "59651-0646-26",
"ProductNDC": "59651-646",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolate Mofetil",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20240926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218227",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240926",
"SamplePackage": "N",
"IndicationAndUsage": "Mycophenolate mofetil for oral suspension (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "Mycophenolate mofetil USP is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. Mycophenolate mofetil USP is a white or almost white crystalline powder. It is practically insoluble in water, freely soluble in acetone, sparingly soluble in anhydrous ethanol. The partition coefficient is 3.47. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil is available for oral administration as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of mycophenolate mofetil USP. Inactive ingredients in mycophenolate mofetil for oral suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, lecithin, methylparaben, powdarome mixed fruit premium (which contains gum arabic, maize maltodextrin and triacetin), sodium citrate (dihydrate), sorbitol and xanthan gum. Each 7.5 mL of mycophenolate mofetil for oral suspension USP contains 18 mg of sodium."
},
{
"NDCCode": "0264-3200-55",
"PackageDescription": "6 CARTON in 1 CASE (0264-3200-55) > 1 BOTTLE, GLASS in 1 CARTON > 1000 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00264-3200-55",
"ProductNDC": "0264-3200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plenamine",
"NonProprietaryName": "Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091112",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
"StrengthNumber": "2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960",
"StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150130",
"SamplePackage": "N"
},
{
"NDCCode": "0264-3205-55",
"PackageDescription": "6 CARTON in 1 CASE (0264-3205-55) > 1 BOTTLE, GLASS in 1 CARTON > 2000 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00264-3205-55",
"ProductNDC": "0264-3205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plenamine",
"NonProprietaryName": "Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091112",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
"StrengthNumber": "2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960",
"StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150130",
"SamplePackage": "N"
},
{
"NDCCode": "0264-4500-00",
"PackageDescription": "8 CONTAINER in 1 CASE (0264-4500-00) / 1000 mL in 1 CONTAINER",
"NDC11Code": "00264-4500-00",
"ProductNDC": "0264-4500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plenamine",
"NonProprietaryName": "Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091112",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; HISTIDINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
"StrengthNumber": "1.18; 1.04; 1.04; 960; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 894; 749; 592; 434; 39",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180928",
"SamplePackage": "N",
"IndicationAndUsage": "Plenamine 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when. — Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy;. — Bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks;. — Tube feeding methods alone cannot provide adequate nutrition.",
"Description": "Plenamine 15% Amino Acids Injection in a Pharmacy Bulk Package is a sterile, clear, nonpyrogenic solution of essential and nonessential amino acids for intravenous infusion in parenteral nutrition following appropriate dilution. Plenamine 15% in a Pharmacy Bulk Package is not for direct infusion. It is a sterile dosage form which contains several single doses for use in a pharmacy admixture program in the preparation of intravenous parenteral fluids. Each 100 mL contains. The formulas for the individual amino acids are as follows."
},
{
"NDCCode": "0264-4500-05",
"PackageDescription": "4 CONTAINER in 1 CASE (0264-4500-05) / 2000 mL in 1 CONTAINER",
"NDC11Code": "00264-4500-05",
"ProductNDC": "0264-4500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plenamine",
"NonProprietaryName": "Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091112",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; HISTIDINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
"StrengthNumber": "1.18; 1.04; 1.04; 960; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 894; 749; 592; 434; 39",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191029",
"SamplePackage": "N",
"IndicationAndUsage": "Plenamine 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when. — Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy;. — Bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks;. — Tube feeding methods alone cannot provide adequate nutrition.",
"Description": "Plenamine 15% Amino Acids Injection in a Pharmacy Bulk Package is a sterile, clear, nonpyrogenic solution of essential and nonessential amino acids for intravenous infusion in parenteral nutrition following appropriate dilution. Plenamine 15% in a Pharmacy Bulk Package is not for direct infusion. It is a sterile dosage form which contains several single doses for use in a pharmacy admixture program in the preparation of intravenous parenteral fluids. Each 100 mL contains. The formulas for the individual amino acids are as follows."
},
{
"NDCCode": "0338-0502-03",
"PackageDescription": "500 mL in 1 BAG (0338-0502-03) ",
"NDC11Code": "00338-0502-03",
"ProductNDC": "0338-0502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinisol",
"NonProprietaryName": "Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19960830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA020512",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; HISTIDINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
"StrengthNumber": "1.18; 1.04; 1.04; 960; 894; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 749; 592; 434; 39",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19960830",
"SamplePackage": "N",
"IndicationAndUsage": "15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.",
"Description": "15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is a sterile, clear, nonpyrogenic, hypertonic solution of essential and nonessential amino acids. 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. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological test for plastic containers as well as by tissue culture toxicity studies. Each 100 mL of 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package contains."
},
{
"NDCCode": "0338-0502-06",
"PackageDescription": "2000 mL in 1 BAG (0338-0502-06) ",
"NDC11Code": "00338-0502-06",
"ProductNDC": "0338-0502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinisol",
"NonProprietaryName": "Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19960830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA020512",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; HISTIDINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
"StrengthNumber": "1.18; 1.04; 1.04; 960; 894; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 749; 592; 434; 39",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19960830",
"SamplePackage": "N",
"IndicationAndUsage": "15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.",
"Description": "15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is a sterile, clear, nonpyrogenic, hypertonic solution of essential and nonessential amino acids. 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. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological test for plastic containers as well as by tissue culture toxicity studies. Each 100 mL of 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package contains."
},
{
"NDCCode": "0409-0468-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (0409-0468-05) > 500 mL in 1 BOTTLE",
"NDC11Code": "00409-0468-05",
"ProductNDC": "0409-0468",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Novamine",
"NonProprietaryName": "Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20111122",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017957",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; HISTIDINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
"StrengthNumber": "1.18; 1.04; 1.04; 960; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 894; 749; 592; 434; 39",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-09-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59651-001-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-001-01) ",
"NDC11Code": "59651-0001-01",
"ProductNDC": "59651-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203270",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150819",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-001-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59651-001-03) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-001-10) ",
"NDC11Code": "59651-0001-03",
"ProductNDC": "59651-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203270",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150819",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-001-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-001-30) ",
"NDC11Code": "59651-0001-30",
"ProductNDC": "59651-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203270",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-001-49",
"PackageDescription": "4000 CAPSULE, DELAYED RELEASE in 1 BAG (59651-001-49) ",
"NDC11Code": "59651-0001-49",
"ProductNDC": "59651-001",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-06-19",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19-AUG-15"
},
{
"NDCCode": "59651-001-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-001-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-001-10) ",
"NDC11Code": "59651-0001-78",
"ProductNDC": "59651-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
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"RouteName": "ORAL",
"StartMarketingDate": "20150819",
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"ApplicationNumber": "ANDA203270",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-001-99",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-001-99) ",
"NDC11Code": "59651-0001-99",
"ProductNDC": "59651-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
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"RouteName": "ORAL",
"StartMarketingDate": "20150819",
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"LabelerName": "Aurobindo Pharma Limited",
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"IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-002-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-01) ",
"NDC11Code": "59651-0002-01",
"ProductNDC": "59651-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203270",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-002-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59651-002-03) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-002-10) ",
"NDC11Code": "59651-0002-03",
"ProductNDC": "59651-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203270",
"LabelerName": "Aurobindo Pharma Limited",
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"StrengthNumber": "20",
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"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-002-05",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-05) ",
"NDC11Code": "59651-0002-05",
"ProductNDC": "59651-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203270",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-002-26",
"PackageDescription": "2500 CAPSULE, DELAYED RELEASE in 1 BAG (59651-002-26) ",
"NDC11Code": "59651-0002-26",
"ProductNDC": "59651-002",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Omeprazole",
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"StartMarketingDate": "20150819",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-06-19",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19-AUG-15"
},
{
"NDCCode": "59651-002-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-30) ",
"NDC11Code": "59651-0002-30",
"ProductNDC": "59651-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203270",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150819",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
}
]
}
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<NDCList>
<NDC>
<NDCCode>59651-960-47</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (59651-960-47) </PackageDescription>
<NDC11Code>59651-0960-47</NDC11Code>
<ProductNDC>59651-960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216536</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>meq/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium Chloride, USP is a white crystalline powder or colourless crystals. It is freely soluble in water, practically insoluble in ethanol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor (contains dl-alpha-Tocopherol), propylene glycol, propylparaben, purified water, sodium citrate and sucralose. Oral Solution 20%: Each 15 mL of solution contains 3 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor (contains dl-alpha-Tocopherol), propylene glycol, propylparaben, purified water, sodium citrate and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>59651-032-47</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59651-032-47) / 473 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>59651-0032-47</NDC11Code>
<ProductNDC>59651-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen Oral</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209178</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen oral suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). In Pediatric Patients, Ibuprofen Oral Suspension is indicated: 1 For reduction of fever in patients aged 6 months up to 2 years of age., 2 For relief of mild to moderate pain in patients aged 6 months up to 2 years of age. , 3 For relief of signs and symptoms of juvenile arthritis. .</IndicationAndUsage>
<Description>The active ingredient in Ibuprofen oral suspension USP is ibuprofen, which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to off-white crystalline powder, with a melting point of 75° to 78°C. It is practically insoluble in water (< 0.1 mg/mL), but very soluble in alcohol, methanol, chloroform and acetone, slightly soluble in ethyl acetate. Ibuprofen has a pKa of 3.6 and an n-octanol/water partition coefficient of 3.3. The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid. The molecular weight of ibuprofen is 206.28. Its molecular formula is C13H18O2 and it has the following structural formula: Ibuprofen oral suspension USP is a light orange to orange colored, berry flavored suspension containing 100 mg of ibuprofen USP in 5 mL (20 mg/mL). Inactive ingredients include: acesulfame potassium, art raspberry, citric acid anhydrous, D&C yellow No. 10, FD & C red No.40, glycerin, hypromellose, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>59651-435-47</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59651-435-47) / 473 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>59651-0435-47</NDC11Code>
<ProductNDC>59651-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214847</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate oral solution is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).</IndicationAndUsage>
<Description>Glycopyrrolate is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate USP per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-,bromide. The chemical structure is. The molecular formula for glycopyrrolate is C19H28BrNO3 and the molecular weight is 398.33. The inactive ingredients in glycopyrrolate oral solution are: citric acid monohydrate, glycerin, methylparaben, N&A strawberry FL Wild, non crystallizing sorbitol solution, propylene glycol, propylparaben, purified water, saccharin sodium and sodium citrate (dihydrate).</Description>
</NDC>
<NDC>
<NDCCode>59651-493-47</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (59651-493-47) </PackageDescription>
<NDC11Code>59651-0493-47</NDC11Code>
<ProductNDC>59651-493</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216331</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections: Acyclovir oral suspension is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir oral suspension is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir oral suspension is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>PRESCRIBING INFORMATION DESCRIPTION Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir oral suspension, USP is a formulation for oral administration. Each teaspoonful (5 mL) of acyclovir oral suspension, USP contains 200 mg of acyclovir USP and the inactive ingredients: banana flavor, carboxymethylcellulose sodium, glycerin, methylparaben 0.1% (added as preservative), microcrystalline cellulose and carboxymethylcellulose sodium, noncrystallizing sorbitol solution, propylene glycol, propylparaben 0.02% (added as preservative), and purified water. Acyclovir, USP is a white or almost white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 1.513 mg/mL. The pka of acyclovir is 9.67. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action: Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
</NDC>
<NDC>
<NDCCode>59651-528-47</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59651-528-47) / 473 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>59651-0528-47</NDC11Code>
<ProductNDC>59651-528</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216504</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen oral suspension is indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis , 2 osteoarthritis , 3 ankylosing spondylitis , 4 polyarticular juvenile idiopathic arthritis , 5 tendonitis , 6 bursitis , 7 acute gout .</IndicationAndUsage>
<Description>Naproxen oral suspension, USP is available as a light orange-colored, pineapple-orange flavored homogenous suspension containing 125 mg/5 mL of naproxen USP for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. The molecular weight is 230.26. Its molecular formula is C14H14O3, and it has the following chemical structure. Naproxen USP is a white to off-white crystalline powder. It is soluble in chloroform, in dehydrated alcohol, and in alcohol, sparingly soluble in ether, practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen oral suspension USP include art pineapple flavor, benzyl alcohol, FD&C yellow No. 6, fumaric acid, magnesium aluminum silicate, methylparaben, modified food starch (corn), nat orange flavor, noncrystallizing sorbitol solution, propylene glycol, purified water, sodium chloride (39 mg/5 mL, 0.667 mEq), sucrose, and xanthan gum. The pH of the suspension ranges from 2.2 to 3.7.</Description>
</NDC>
<NDC>
<NDCCode>59651-687-47</NDCCode>
<PackageDescription>115000 TABLET in 1 BAG (59651-687-47) </PackageDescription>
<NDC11Code>59651-0687-47</NDC11Code>
<ProductNDC>59651-687</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Fluphenazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20230818</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FLUPHENAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-08-25</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-AUG-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-959-47</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (59651-959-47) </PackageDescription>
<NDC11Code>59651-0959-47</NDC11Code>
<ProductNDC>59651-959</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216536</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>meq/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium Chloride, USP is a white crystalline powder or colourless crystals. It is freely soluble in water, practically insoluble in ethanol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor (contains dl-alpha-Tocopherol), propylene glycol, propylparaben, purified water, sodium citrate and sucralose. Oral Solution 20%: Each 15 mL of solution contains 3 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor (contains dl-alpha-Tocopherol), propylene glycol, propylparaben, purified water, sodium citrate and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>59651-152-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (59651-152-01) </PackageDescription>
<NDC11Code>59651-0152-01</NDC11Code>
<ProductNDC>59651-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Progesterone</ProprietaryName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211285</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.</IndicationAndUsage>
<Description>Progesterone capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, crystalline powder or colorless crystals practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, melting between 126º and 131ºC. The structural formula is. Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain 100 mg or 200 mg micronized progesterone USP. The inactive ingredients for progesterone capsules include: gelatin, glycerin, hypromellose, iron oxide black, lecithin, peanut oil, propylene glycol, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59651-153-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (59651-153-01) </PackageDescription>
<NDC11Code>59651-0153-01</NDC11Code>
<ProductNDC>59651-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Progesterone</ProprietaryName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211285</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.</IndicationAndUsage>
<Description>Progesterone capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, crystalline powder or colorless crystals practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, melting between 126º and 131ºC. The structural formula is. Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain 100 mg or 200 mg micronized progesterone USP. The inactive ingredients for progesterone capsules include: gelatin, glycerin, hypromellose, iron oxide black, lecithin, peanut oil, propylene glycol, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59651-638-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59651-638-01) </PackageDescription>
<NDC11Code>59651-0638-01</NDC11Code>
<ProductNDC>59651-638</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217937</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. Mycophenolate mofetil USP is a white or almost white crystalline powder. It is practically insoluble in water, freely soluble in acetone, sparingly soluble in anhydrous ethanol. The partition coefficient is 3.47. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil USP is available for oral administration as tablets containing 500 mg of mycophenolate mofetil USP. Inactive ingredients in mycophenolate mofetil tablets USP, 500 mg include colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>59651-638-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (59651-638-05) </PackageDescription>
<NDC11Code>59651-0638-05</NDC11Code>
<ProductNDC>59651-638</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217937</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. Mycophenolate mofetil USP is a white or almost white crystalline powder. It is practically insoluble in water, freely soluble in acetone, sparingly soluble in anhydrous ethanol. The partition coefficient is 3.47. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil USP is available for oral administration as tablets containing 500 mg of mycophenolate mofetil USP. Inactive ingredients in mycophenolate mofetil tablets USP, 500 mg include colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>59651-646-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59651-646-26) / 225 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>59651-0646-26</NDC11Code>
<ProductNDC>59651-646</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218227</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mycophenolate mofetil for oral suspension (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>Mycophenolate mofetil USP is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. Mycophenolate mofetil USP is a white or almost white crystalline powder. It is practically insoluble in water, freely soluble in acetone, sparingly soluble in anhydrous ethanol. The partition coefficient is 3.47. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil is available for oral administration as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of mycophenolate mofetil USP. Inactive ingredients in mycophenolate mofetil for oral suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, lecithin, methylparaben, powdarome mixed fruit premium (which contains gum arabic, maize maltodextrin and triacetin), sodium citrate (dihydrate), sorbitol and xanthan gum. Each 7.5 mL of mycophenolate mofetil for oral suspension USP contains 18 mg of sodium.</Description>
</NDC>
<NDC>
<NDCCode>0264-3200-55</NDCCode>
<PackageDescription>6 CARTON in 1 CASE (0264-3200-55) > 1 BOTTLE, GLASS in 1 CARTON > 1000 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00264-3200-55</NDC11Code>
<ProductNDC>0264-3200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plenamine</ProprietaryName>
<NonProprietaryName>Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091112</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE</SubstanceName>
<StrengthNumber>2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0264-3205-55</NDCCode>
<PackageDescription>6 CARTON in 1 CASE (0264-3205-55) > 1 BOTTLE, GLASS in 1 CARTON > 2000 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00264-3205-55</NDC11Code>
<ProductNDC>0264-3205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plenamine</ProprietaryName>
<NonProprietaryName>Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091112</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE</SubstanceName>
<StrengthNumber>2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0264-4500-00</NDCCode>
<PackageDescription>8 CONTAINER in 1 CASE (0264-4500-00) / 1000 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4500-00</NDC11Code>
<ProductNDC>0264-4500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plenamine</ProprietaryName>
<NonProprietaryName>Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091112</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; HISTIDINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE</SubstanceName>
<StrengthNumber>1.18; 1.04; 1.04; 960; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 894; 749; 592; 434; 39</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Plenamine 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when. — Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy;. — Bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks;. — Tube feeding methods alone cannot provide adequate nutrition.</IndicationAndUsage>
<Description>Plenamine 15% Amino Acids Injection in a Pharmacy Bulk Package is a sterile, clear, nonpyrogenic solution of essential and nonessential amino acids for intravenous infusion in parenteral nutrition following appropriate dilution. Plenamine 15% in a Pharmacy Bulk Package is not for direct infusion. It is a sterile dosage form which contains several single doses for use in a pharmacy admixture program in the preparation of intravenous parenteral fluids. Each 100 mL contains. The formulas for the individual amino acids are as follows.</Description>
</NDC>
<NDC>
<NDCCode>0264-4500-05</NDCCode>
<PackageDescription>4 CONTAINER in 1 CASE (0264-4500-05) / 2000 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-4500-05</NDC11Code>
<ProductNDC>0264-4500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plenamine</ProprietaryName>
<NonProprietaryName>Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091112</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; HISTIDINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE</SubstanceName>
<StrengthNumber>1.18; 1.04; 1.04; 960; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 894; 749; 592; 434; 39</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Plenamine 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when. — Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy;. — Bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks;. — Tube feeding methods alone cannot provide adequate nutrition.</IndicationAndUsage>
<Description>Plenamine 15% Amino Acids Injection in a Pharmacy Bulk Package is a sterile, clear, nonpyrogenic solution of essential and nonessential amino acids for intravenous infusion in parenteral nutrition following appropriate dilution. Plenamine 15% in a Pharmacy Bulk Package is not for direct infusion. It is a sterile dosage form which contains several single doses for use in a pharmacy admixture program in the preparation of intravenous parenteral fluids. Each 100 mL contains. The formulas for the individual amino acids are as follows.</Description>
</NDC>
<NDC>
<NDCCode>0338-0502-03</NDCCode>
<PackageDescription>500 mL in 1 BAG (0338-0502-03) </PackageDescription>
<NDC11Code>00338-0502-03</NDC11Code>
<ProductNDC>0338-0502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinisol</ProprietaryName>
<NonProprietaryName>Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19960830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA020512</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; HISTIDINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE</SubstanceName>
<StrengthNumber>1.18; 1.04; 1.04; 960; 894; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 749; 592; 434; 39</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.</IndicationAndUsage>
<Description>15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is a sterile, clear, nonpyrogenic, hypertonic solution of essential and nonessential amino acids. 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. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological test for plastic containers as well as by tissue culture toxicity studies. Each 100 mL of 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package contains.</Description>
</NDC>
<NDC>
<NDCCode>0338-0502-06</NDCCode>
<PackageDescription>2000 mL in 1 BAG (0338-0502-06) </PackageDescription>
<NDC11Code>00338-0502-06</NDC11Code>
<ProductNDC>0338-0502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinisol</ProprietaryName>
<NonProprietaryName>Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19960830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA020512</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; HISTIDINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE</SubstanceName>
<StrengthNumber>1.18; 1.04; 1.04; 960; 894; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 749; 592; 434; 39</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.</IndicationAndUsage>
<Description>15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is a sterile, clear, nonpyrogenic, hypertonic solution of essential and nonessential amino acids. 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. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological test for plastic containers as well as by tissue culture toxicity studies. Each 100 mL of 15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package contains.</Description>
</NDC>
<NDC>
<NDCCode>0409-0468-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0409-0468-05) > 500 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00409-0468-05</NDC11Code>
<ProductNDC>0409-0468</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Novamine</ProprietaryName>
<NonProprietaryName>Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20111122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017957</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; HISTIDINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE</SubstanceName>
<StrengthNumber>1.18; 1.04; 1.04; 960; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 894; 749; 592; 434; 39</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-09-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59651-001-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-001-01) </PackageDescription>
<NDC11Code>59651-0001-01</NDC11Code>
<ProductNDC>59651-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203270</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>59651-001-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59651-001-03) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-001-10) </PackageDescription>
<NDC11Code>59651-0001-03</NDC11Code>
<ProductNDC>59651-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203270</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-19</LastUpdate>
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<IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
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