{
"NDC": [
{
"NDCCode": "71655-578-08",
"PackageDescription": "8 CARTON in 1 BOX (71655-578-08) / 36 VIAL, GLASS in 1 CARTON (71655-578-02) / 8 mL in 1 VIAL, GLASS (71655-578-01) ",
"NDC11Code": "71655-0578-08",
"ProductNDC": "71655-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ebanga",
"NonProprietaryName": "Ansuvimab",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201221",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761172",
"LabelerName": "Emergent BioDefense Operations Lansing LLC",
"SubstanceName": "ANSUVIMAB",
"StrengthNumber": "400",
"StrengthUnit": "mg/8mL",
"Pharm_Classes": "Zaire Ebolavirus Glycoprotein-directed Antibody Interactions [MoA], Zaire Ebolavirus Glycoprotein-directed Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201221",
"SamplePackage": "N",
"IndicationAndUsage": "EBANGA is indicated for the treatment of infection caused by Orthoebolavirus zairense (formerly Zaire ebolavirus)in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2)and Clinical Studies (14)].",
"Description": "Ansuvimab-zykl is an Orthoebolavirus zairense(EBOV) glycoprotein 1 (GP1)-directed recombinant, human IgG1 monoclonal antibody. Ansuvimab-zykl is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and has an approximate molecular weight of 147 kDa. EBANGA (ansuvimab-zykl) for injection is a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial for IV use after reconstitution and dilution. Each single-dose vial delivers 400 mg of ansuvimab-zykl, and L-histidine (12.4 mg), L-histidine HCl (16.8 mg), polysorbate 80 (1.6 mg), and sucrose (657 mg). After reconstitution with 7.7 mL of Sterile Water for Injection, USP, each vial delivers 8 mL of a clear and colorless to slightly yellow solution containing 50 mg/mL of ansuvimab-zykl, with an approximate pH of 6."
},
{
"NDCCode": "71655-578-03",
"PackageDescription": "1 CARTON in 1 BOX (71655-578-03) / 36 VIAL, GLASS in 1 CARTON (71655-578-02) / 8 mL in 1 VIAL, GLASS (71655-578-01) ",
"NDC11Code": "71655-0578-03",
"ProductNDC": "71655-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ebanga",
"NonProprietaryName": "Ansuvimab",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201221",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761172",
"LabelerName": "Emergent BioDefense Operations Lansing LLC",
"SubstanceName": "ANSUVIMAB",
"StrengthNumber": "400",
"StrengthUnit": "mg/8mL",
"Pharm_Classes": "Zaire Ebolavirus Glycoprotein-directed Antibody Interactions [MoA], Zaire Ebolavirus Glycoprotein-directed Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201221",
"SamplePackage": "N",
"IndicationAndUsage": "EBANGA is indicated for the treatment of infection caused by Orthoebolavirus zairense (formerly Zaire ebolavirus)in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2)and Clinical Studies (14)].",
"Description": "Ansuvimab-zykl is an Orthoebolavirus zairense(EBOV) glycoprotein 1 (GP1)-directed recombinant, human IgG1 monoclonal antibody. Ansuvimab-zykl is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and has an approximate molecular weight of 147 kDa. EBANGA (ansuvimab-zykl) for injection is a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial for IV use after reconstitution and dilution. Each single-dose vial delivers 400 mg of ansuvimab-zykl, and L-histidine (12.4 mg), L-histidine HCl (16.8 mg), polysorbate 80 (1.6 mg), and sucrose (657 mg). After reconstitution with 7.7 mL of Sterile Water for Injection, USP, each vial delivers 8 mL of a clear and colorless to slightly yellow solution containing 50 mg/mL of ansuvimab-zykl, with an approximate pH of 6."
},
{
"NDCCode": "71655-578-04",
"PackageDescription": "4 CARTON in 1 BOX (71655-578-04) / 36 VIAL, GLASS in 1 CARTON (71655-578-02) / 8 mL in 1 VIAL, GLASS (71655-578-01) ",
"NDC11Code": "71655-0578-04",
"ProductNDC": "71655-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ebanga",
"NonProprietaryName": "Ansuvimab",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201221",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761172",
"LabelerName": "Emergent BioDefense Operations Lansing LLC",
"SubstanceName": "ANSUVIMAB",
"StrengthNumber": "400",
"StrengthUnit": "mg/8mL",
"Pharm_Classes": "Zaire Ebolavirus Glycoprotein-directed Antibody Interactions [MoA], Zaire Ebolavirus Glycoprotein-directed Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201221",
"SamplePackage": "N",
"IndicationAndUsage": "EBANGA is indicated for the treatment of infection caused by Orthoebolavirus zairense (formerly Zaire ebolavirus)in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2)and Clinical Studies (14)].",
"Description": "Ansuvimab-zykl is an Orthoebolavirus zairense(EBOV) glycoprotein 1 (GP1)-directed recombinant, human IgG1 monoclonal antibody. Ansuvimab-zykl is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and has an approximate molecular weight of 147 kDa. EBANGA (ansuvimab-zykl) for injection is a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial for IV use after reconstitution and dilution. Each single-dose vial delivers 400 mg of ansuvimab-zykl, and L-histidine (12.4 mg), L-histidine HCl (16.8 mg), polysorbate 80 (1.6 mg), and sucrose (657 mg). After reconstitution with 7.7 mL of Sterile Water for Injection, USP, each vial delivers 8 mL of a clear and colorless to slightly yellow solution containing 50 mg/mL of ansuvimab-zykl, with an approximate pH of 6."
},
{
"NDCCode": "42549-578-08",
"PackageDescription": "168 TABLET in 1 BOTTLE (42549-578-08)",
"NDC11Code": "42549-0578-08",
"ProductNDC": "42549-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040517",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.",
"Description": "Methadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. The tablets also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide."
},
{
"NDCCode": "71919-578-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-578-08) ",
"NDC11Code": "71919-0578-08",
"ProductNDC": "71919-578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rhamnus Purshiana",
"NonProprietaryName": "Frangula Purshiana Bark",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090114",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FRANGULA PURSHIANA BARK",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20090114",
"SamplePackage": "N"
},
{
"NDCCode": "21749-578-01",
"PackageDescription": "30 mL in 1 PACKAGE (21749-578-01) ",
"NDC11Code": "21749-0578-01",
"ProductNDC": "21749-578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purell Advanced Hand Sanitizer Blushing Pink Orchid",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160501",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160501",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "59676-578-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (59676-578-30) ",
"NDC11Code": "59676-0578-30",
"ProductNDC": "59676-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prezcobix",
"NonProprietaryName": "Darunavir Ethanolate And Cobicistat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250321",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205395",
"LabelerName": "Janssen Products, LP",
"SubstanceName": "DARUNAVIR ETHANOLATE; COBICISTAT",
"StrengthNumber": "675; 150",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250321",
"SamplePackage": "N",
"IndicationAndUsage": "PREZCOBIX and PREZCOBIX PED are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) [see Use in Specific Populations (8.4) and Clinical Studies (14)].",
"Description": "PREZCOBIX and PREZCOBIX PED are fixed-dose combination products containing darunavir and cobicistat. Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family. Darunavir: Darunavir, in the form of darunavir ethanolate, has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester monoethanolate. Its molecular formula is C27H37N3O7S ∙ C2H5OH and its molecular weight is 593.73. Darunavir ethanolate has the following structural formula. Cobicistat: Cobicistat is adsorbed onto silicon dioxide. The chemical name for cobicistat is 1,3-thiazol-5-ylmethyl[(2R,5R)-5-{[(2S)2-[(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}carbamoyl)amino]-4-(morpholin-4yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate. It has a molecular formula of C40H53N7O5S2 and a molecular weight of 776.0. It has the following structural formula. PREZCOBIX® 800 mg darunavir/150 mg cobicistat tablets are for oral administration. Each tablet contains darunavir ethanolate equivalent to 800 mg of darunavir and 150 mg of cobicistat. The tablets include the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, and silicified microcrystalline cellulose. The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. PREZCOBIX® 675 mg darunavir/150 mg cobicistat tablets are for oral administration. Each tablet contains darunavir ethanolate equivalent to 675 mg of darunavir and 150 mg of cobicistat. The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. PREZCOBIX® PED 600 mg darunavir/90 mg cobicistat tablets for oral suspension are for oral administration. Each tablet for oral suspension contains darunavir ethanolate equivalent to 600 mg of darunavir and 90 mg of cobicistat. The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, silicified microcrystalline cellulose, strawberry flavor, and sucralose. The tablets are film-coated with a coating material containing glycerol monocaprylocaprate type 1, iron oxide red, iron oxide black, macrogol polyvinyl alcohol graft copolymer, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide."
},
{
"NDCCode": "61621-430-01",
"PackageDescription": "1 TABLET in 1 POUCH (61621-430-01) ",
"NDC11Code": "61621-0430-01",
"ProductNDC": "61621-430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dsuvia",
"NonProprietaryName": "Sufentanil",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20181102",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209128",
"LabelerName": "AcelRx Pharmaceuticals, Inc.",
"SubstanceName": "SUFENTANIL",
"StrengthNumber": "30",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181102",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting. , 2 Not for use for more than 72 hours. The use of DSUVIA beyond 72 hours has not been studied., 3 Only to be administered by a healthcare provider., 4 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, [see Warnings and Precautions (5.3)], reserve opioid analgesics, including DSUVIA, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "DSUVIA contains one 30 mcg sufentanil tablet housed in a disposable single-dose applicator (SDA). The DSUVIA tablet is an immediate release formulation intended for sublingual administration. Each tablet is blue, flat-faced with a diameter of 3 mm. The IUPAC chemical name for sufentanil is N-[4-(methoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide citrate. Sufentanil citrate has a molecular weight of 578.4 (molecular weight of free sufentanil base is 386.55), its empirical formula is C 28H 38N 2O 9S ● C 6H 8N 2O 7, and its chemical structure is shown below:. DSUVIA tablets inactive ingredients are: mannitol; dicalcium phosphate anhydrous; hypromellose; croscarmellose sodium; FD&C Blue #2; stearic acid and magnesium stearate."
},
{
"NDCCode": "61621-430-11",
"PackageDescription": "10 TABLET in 1 CARTON (61621-430-11) ",
"NDC11Code": "61621-0430-11",
"ProductNDC": "61621-430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dsuvia",
"NonProprietaryName": "Sufentanil",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20181102",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209128",
"LabelerName": "AcelRx Pharmaceuticals, Inc.",
"SubstanceName": "SUFENTANIL",
"StrengthNumber": "30",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181102",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting. , 2 Not for use for more than 72 hours. The use of DSUVIA beyond 72 hours has not been studied., 3 Only to be administered by a healthcare provider., 4 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, [see Warnings and Precautions (5.3)], reserve opioid analgesics, including DSUVIA, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "DSUVIA contains one 30 mcg sufentanil tablet housed in a disposable single-dose applicator (SDA). The DSUVIA tablet is an immediate release formulation intended for sublingual administration. Each tablet is blue, flat-faced with a diameter of 3 mm. The IUPAC chemical name for sufentanil is N-[4-(methoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide citrate. Sufentanil citrate has a molecular weight of 578.4 (molecular weight of free sufentanil base is 386.55), its empirical formula is C 28H 38N 2O 9S ● C 6H 8N 2O 7, and its chemical structure is shown below:. DSUVIA tablets inactive ingredients are: mannitol; dicalcium phosphate anhydrous; hypromellose; croscarmellose sodium; FD&C Blue #2; stearic acid and magnesium stearate."
},
{
"NDCCode": "63323-578-01",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-03) ",
"NDC11Code": "63323-0578-01",
"ProductNDC": "63323-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20171027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209328",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171027",
"SamplePackage": "N",
"IndicationAndUsage": "Anesthesia. Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. Peptic Ulcer. For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.",
"Description": "Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains: Glycopyrrolate, 0.2 mg; water for injection, q.s.; benzyl alcohol, 0.9% (preservative); pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide.Its structural formula is as follows: C19H28BrNO3 M.W. 398.33Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol /water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C)."
},
{
"NDCCode": "63323-578-02",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-578-04) ",
"NDC11Code": "63323-0578-02",
"ProductNDC": "63323-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20171027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209328",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171027",
"SamplePackage": "N",
"IndicationAndUsage": "Anesthesia. Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. Peptic Ulcer. For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.",
"Description": "Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains: Glycopyrrolate, 0.2 mg; water for injection, q.s.; benzyl alcohol, 0.9% (preservative); pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide.Its structural formula is as follows: C19H28BrNO3 M.W. 398.33Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol /water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C)."
},
{
"NDCCode": "63323-578-05",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (63323-578-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-578-07) ",
"NDC11Code": "63323-0578-05",
"ProductNDC": "63323-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20171027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209328",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171027",
"SamplePackage": "N",
"IndicationAndUsage": "Anesthesia. Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. Peptic Ulcer. For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.",
"Description": "Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains: Glycopyrrolate, 0.2 mg; water for injection, q.s.; benzyl alcohol, 0.9% (preservative); pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide.Its structural formula is as follows: C19H28BrNO3 M.W. 398.33Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol /water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C)."
},
{
"NDCCode": "70550-578-01",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (70550-578-01) / 60 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "70550-0578-01",
"ProductNDC": "70550-578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Keranique Hair Regrowth Treatment For Women",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078176",
"LabelerName": "PROFECTUS BEAUTY, LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240717",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the scalp."
},
{
"NDCCode": "70550-578-02",
"PackageDescription": "2 BOTTLE, SPRAY in 1 BOX (70550-578-02) / 60 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "70550-0578-02",
"ProductNDC": "70550-578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Keranique Hair Regrowth Treatment For Women",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078176",
"LabelerName": "PROFECTUS BEAUTY, LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240717",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the scalp."
},
{
"NDCCode": "70550-578-03",
"PackageDescription": "3 BOTTLE, SPRAY in 1 BOX (70550-578-03) / 60 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "70550-0578-03",
"ProductNDC": "70550-578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Keranique Hair Regrowth Treatment For Women",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078176",
"LabelerName": "PROFECTUS BEAUTY, LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240717",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the scalp."
},
{
"NDCCode": "70550-578-04",
"PackageDescription": "4 BOTTLE, SPRAY in 1 BOX (70550-578-04) / 60 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "70550-0578-04",
"ProductNDC": "70550-578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Keranique Hair Regrowth Treatment For Women",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078176",
"LabelerName": "PROFECTUS BEAUTY, LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240717",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the scalp."
},
{
"NDCCode": "71205-578-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (71205-578-30) ",
"NDC11Code": "71205-0578-30",
"ProductNDC": "71205-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206261",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"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": "2022-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210610",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections: Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules are formulations for oral administration. Each capsule of Acyclovir contains 200 mg of acyclovir and the inactive ingredients: lactose monohydrate, sodium lauryl sulfate, corn starch, and magnesium stearate. The capsule shell consists of FD&C Blue #1, gelatin, and titanium dioxide. The imprinting ink contains, alcohol, FD&C Blue #2, FD&C Red #40, FD&C Yellow#10, iron oxide black, shellac Glaze. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6 H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:."
},
{
"NDCCode": "71205-578-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (71205-578-60) ",
"NDC11Code": "71205-0578-60",
"ProductNDC": "71205-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206261",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"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": "2022-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210610",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections: Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules are formulations for oral administration. Each capsule of Acyclovir contains 200 mg of acyclovir and the inactive ingredients: lactose monohydrate, sodium lauryl sulfate, corn starch, and magnesium stearate. The capsule shell consists of FD&C Blue #1, gelatin, and titanium dioxide. The imprinting ink contains, alcohol, FD&C Blue #2, FD&C Red #40, FD&C Yellow#10, iron oxide black, shellac Glaze. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6 H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:."
},
{
"NDCCode": "71205-578-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (71205-578-90) ",
"NDC11Code": "71205-0578-90",
"ProductNDC": "71205-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206261",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"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": "2022-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210610",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections: Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules are formulations for oral administration. Each capsule of Acyclovir contains 200 mg of acyclovir and the inactive ingredients: lactose monohydrate, sodium lauryl sulfate, corn starch, and magnesium stearate. The capsule shell consists of FD&C Blue #1, gelatin, and titanium dioxide. The imprinting ink contains, alcohol, FD&C Blue #2, FD&C Red #40, FD&C Yellow#10, iron oxide black, shellac Glaze. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6 H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:."
},
{
"NDCCode": "71610-578-60",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-60) ",
"NDC11Code": "71610-0578-60",
"ProductNDC": "71610-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206145",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2021-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210701",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate and copovidone. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "71610-578-70",
"PackageDescription": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-70) ",
"NDC11Code": "71610-0578-70",
"ProductNDC": "71610-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206145",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2021-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210701",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate and copovidone. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "71610-578-80",
"PackageDescription": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-80) ",
"NDC11Code": "71610-0578-80",
"ProductNDC": "71610-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206145",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2021-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210701",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate and copovidone. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "71610-578-94",
"PackageDescription": "360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-94) ",
"NDC11Code": "71610-0578-94",
"ProductNDC": "71610-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206145",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2021-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210701",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate and copovidone. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72603-578-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (72603-578-01) / 100 mL in 1 BOTTLE",
"NDC11Code": "72603-0578-01",
"ProductNDC": "72603-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201404",
"LabelerName": "NorthStar Rx, LLC",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240301",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
"Description": "Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin for intravenous use. The pharmacy bulk package contains sterile ampicillin sodium equivalent to 10 grams ampicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Grampositive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates.A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package). It has the following molecular structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10. The pH range of the reconstituted solution is 8 to 10. Ampicillin for Injection, USP contains 65.83 mg (2.86 milliequivalents) of sodium per 1 gram of drug. Ampicillin for Injection, USP is white to off-white crystalline powder. The solution after reconstitution is clear and colorless. Each Ampicillin for Injection Pharmacy Bulk Package bottle contains ampicillin sodium equivalent to 10 grams of ampicillin."
},
{
"NDCCode": "72789-578-20",
"PackageDescription": "20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-578-20) ",
"NDC11Code": "72789-0578-20",
"ProductNDC": "72789-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077863",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260812",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
"Description": "Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow."
},
{
"NDCCode": "72789-578-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-578-30) ",
"NDC11Code": "72789-0578-30",
"ProductNDC": "72789-578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077863",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260629",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
"Description": "Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow."
},
{
"NDCCode": "71655-103-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (71655-103-01) / 34 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "71655-0103-01",
"ProductNDC": "71655-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Raxibacumab",
"NonProprietaryName": "Raxibacumab",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20121214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125349",
"LabelerName": "Emergent BioDefense Operations Lansing",
"SubstanceName": "RAXIBACUMAB",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthrax Protective Antigen-directed Antibody Interactions [MoA], Anthrax Protective Antigen-directed Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121214",
"SamplePackage": "N",
"IndicationAndUsage": "Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracisin combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ( 1.1). Limitations of Use: 1 The effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. ( 1.2, 14.1) , 2 There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using an extrapolation approach. ( 1.2, 8.4) , 3 Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis. Raxibacumab should be used in combination with appropriate antibacterial drugs. ( 1.2) .",
"Description": "Raxibacumab is a human IgG1λ monoclonal antibody that binds the PA component of B. anthracistoxin. Raxibacumab has a molecular weight of approximately 146 kilodaltons. Raxibacumab is produced by recombinant DNA technology in a murine cell expression system. Raxibacumab is supplied as a sterile, preservative-free, clear to opalescent, colorless to pale yellow liquid formulation in single-use vials for intravenous infusion. Each vial contains 1,700 mg/34 mL (50 mg/mL) raxibacumab in citric acid (0.13 mg/mL), glycine (18 mg/mL), polysorbate 80 [0.2 mg/mL (w/v)], sodium citrate (2.8 mg/mL), sucrose (10 mg/mL), and Water for Injection, with a pH of 6.5."
},
{
"NDCCode": "0173-0956-76",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0173-0956-76) / 8 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00173-0956-76",
"ProductNDC": "0173-0956",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Utebzi",
"NonProprietaryName": "Tebipenem Pivoxil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215960",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "TEBIPENEM PIVOXIL HYDROBROMIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "UTEBZI is a penem antibacterial indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis in adult patients who have limited or no alternative oral treatment options. (1.1). Usage to Reduce Development of Drug‑Resistant Bacteria. To reduce the development of drug‑resistant bacteria and maintain the effectiveness of UTEBZI and other antibacterial drugs, UTEBZI should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.2).",
"Description": "UTEBZI (tebipenem pivoxil) tablets, for oral use, contain tebipenem pivoxil hydrobromide, the hydrobromide salt of tebipenem pivoxil, a prodrug of tebipenem, a carbapenem antibacterial. The chemical name is (pivaloyloxy)methyl (4R,5S,6S)-3-((1-(4,5-dihydrothiazol-2-yl)azetidin-3-yl)thio)-6-((R)-1-hydroxyethyl)-4-methyl-7-oxo-1-azabicylo[3.2.0]hept-2-ene-2-carboxylate hydrobromide. The empirical formula is C22H32BrN3O6S2 and the molecular weight is 578.54 g/mol. The structural formula of tebipenem pivoxil hydrobromide is shown below. Tebipenem pivoxil hydrobromide is a white to off-white powder and is sparingly soluble in water. Each film‑coated UTEBZI tablet contains 300 mg tebipenem pivoxil, present as 348.8 mg tebipenem pivoxil hydrobromide and the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The tablet film‑coating consists of FD&C blue 1, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "0409-3382-21",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3382-21) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-3382-11) ",
"NDC11Code": "00409-3382-21",
"ProductNDC": "0409-3382",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sufentanil Citrate",
"NonProprietaryName": "Sufentanil Citrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INTRAVENOUS",
"StartMarketingDate": "20050726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074534",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SUFENTANIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050726",
"SamplePackage": "N",
"IndicationAndUsage": "Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients: 1 as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated., 2 as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.",
"Description": "Sufentanil Citrate Injection, USP is a sterile, nonpyrogenic solution of sufentanil citrate in water for injection. Sufentanil Citrate is a potent opioid analgesic which is administered either epidurally or by intravenous injection. Each mL contains sufentanil citrate equivalent to 50 mcg of sufentanil. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 4.2 (3.5 to 6.0). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-use injection. When smaller doses are required, the unused portion should be discarded in an appropriate manner. Sufentanil Citrate, USP, occurs as a white crystalline powder and is chemically designated as N-[-4-(methyoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The molecular formula of sufentanil citrate is C22H30N2O2S∙C6H8O7 and the molecular weight is 578.69. Sufentanil Citrate has the following structural formula."
},
{
"NDCCode": "0519-8802-13",
"PackageDescription": "444 mL in 1 BOTTLE, PLASTIC (0519-8802-13) ",
"NDC11Code": "00519-8802-13",
"ProductNDC": "0519-8802",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140908",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Steris Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "578",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20140908",
"SamplePackage": "N",
"IndicationAndUsage": "Healthcare Personnel Handwash to decrease bacteria on the skin before contact with patients under medical care or treatment."
}
]
}
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<NDCList>
<NDC>
<NDCCode>71655-578-08</NDCCode>
<PackageDescription>8 CARTON in 1 BOX (71655-578-08) / 36 VIAL, GLASS in 1 CARTON (71655-578-02) / 8 mL in 1 VIAL, GLASS (71655-578-01) </PackageDescription>
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<ProductNDC>71655-578</ProductNDC>
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<ProprietaryName>Ebanga</ProprietaryName>
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<StrengthUnit>mg/8mL</StrengthUnit>
<Pharm_Classes>Zaire Ebolavirus Glycoprotein-directed Antibody Interactions [MoA], Zaire Ebolavirus Glycoprotein-directed Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EBANGA is indicated for the treatment of infection caused by Orthoebolavirus zairense (formerly Zaire ebolavirus)in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2)and Clinical Studies (14)].</IndicationAndUsage>
<Description>Ansuvimab-zykl is an Orthoebolavirus zairense(EBOV) glycoprotein 1 (GP1)-directed recombinant, human IgG1 monoclonal antibody. Ansuvimab-zykl is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and has an approximate molecular weight of 147 kDa. EBANGA (ansuvimab-zykl) for injection is a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial for IV use after reconstitution and dilution. Each single-dose vial delivers 400 mg of ansuvimab-zykl, and L-histidine (12.4 mg), L-histidine HCl (16.8 mg), polysorbate 80 (1.6 mg), and sucrose (657 mg). After reconstitution with 7.7 mL of Sterile Water for Injection, USP, each vial delivers 8 mL of a clear and colorless to slightly yellow solution containing 50 mg/mL of ansuvimab-zykl, with an approximate pH of 6.</Description>
</NDC>
<NDC>
<NDCCode>71655-578-03</NDCCode>
<PackageDescription>1 CARTON in 1 BOX (71655-578-03) / 36 VIAL, GLASS in 1 CARTON (71655-578-02) / 8 mL in 1 VIAL, GLASS (71655-578-01) </PackageDescription>
<NDC11Code>71655-0578-03</NDC11Code>
<ProductNDC>71655-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ebanga</ProprietaryName>
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<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201221</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761172</ApplicationNumber>
<LabelerName>Emergent BioDefense Operations Lansing LLC</LabelerName>
<SubstanceName>ANSUVIMAB</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/8mL</StrengthUnit>
<Pharm_Classes>Zaire Ebolavirus Glycoprotein-directed Antibody Interactions [MoA], Zaire Ebolavirus Glycoprotein-directed Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EBANGA is indicated for the treatment of infection caused by Orthoebolavirus zairense (formerly Zaire ebolavirus)in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2)and Clinical Studies (14)].</IndicationAndUsage>
<Description>Ansuvimab-zykl is an Orthoebolavirus zairense(EBOV) glycoprotein 1 (GP1)-directed recombinant, human IgG1 monoclonal antibody. Ansuvimab-zykl is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and has an approximate molecular weight of 147 kDa. EBANGA (ansuvimab-zykl) for injection is a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial for IV use after reconstitution and dilution. Each single-dose vial delivers 400 mg of ansuvimab-zykl, and L-histidine (12.4 mg), L-histidine HCl (16.8 mg), polysorbate 80 (1.6 mg), and sucrose (657 mg). After reconstitution with 7.7 mL of Sterile Water for Injection, USP, each vial delivers 8 mL of a clear and colorless to slightly yellow solution containing 50 mg/mL of ansuvimab-zykl, with an approximate pH of 6.</Description>
</NDC>
<NDC>
<NDCCode>71655-578-04</NDCCode>
<PackageDescription>4 CARTON in 1 BOX (71655-578-04) / 36 VIAL, GLASS in 1 CARTON (71655-578-02) / 8 mL in 1 VIAL, GLASS (71655-578-01) </PackageDescription>
<NDC11Code>71655-0578-04</NDC11Code>
<ProductNDC>71655-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ebanga</ProprietaryName>
<NonProprietaryName>Ansuvimab</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201221</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761172</ApplicationNumber>
<LabelerName>Emergent BioDefense Operations Lansing LLC</LabelerName>
<SubstanceName>ANSUVIMAB</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/8mL</StrengthUnit>
<Pharm_Classes>Zaire Ebolavirus Glycoprotein-directed Antibody Interactions [MoA], Zaire Ebolavirus Glycoprotein-directed Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EBANGA is indicated for the treatment of infection caused by Orthoebolavirus zairense (formerly Zaire ebolavirus)in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2)and Clinical Studies (14)].</IndicationAndUsage>
<Description>Ansuvimab-zykl is an Orthoebolavirus zairense(EBOV) glycoprotein 1 (GP1)-directed recombinant, human IgG1 monoclonal antibody. Ansuvimab-zykl is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and has an approximate molecular weight of 147 kDa. EBANGA (ansuvimab-zykl) for injection is a sterile, preservative-free, off-white to white lyophilized powder in a single-dose vial for IV use after reconstitution and dilution. Each single-dose vial delivers 400 mg of ansuvimab-zykl, and L-histidine (12.4 mg), L-histidine HCl (16.8 mg), polysorbate 80 (1.6 mg), and sucrose (657 mg). After reconstitution with 7.7 mL of Sterile Water for Injection, USP, each vial delivers 8 mL of a clear and colorless to slightly yellow solution containing 50 mg/mL of ansuvimab-zykl, with an approximate pH of 6.</Description>
</NDC>
<NDC>
<NDCCode>42549-578-08</NDCCode>
<PackageDescription>168 TABLET in 1 BOTTLE (42549-578-08)</PackageDescription>
<NDC11Code>42549-0578-08</NDC11Code>
<ProductNDC>42549-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040517</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
<Description>Methadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. The tablets also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71919-578-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-578-08) </PackageDescription>
<NDC11Code>71919-0578-08</NDC11Code>
<ProductNDC>71919-578</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rhamnus Purshiana</ProprietaryName>
<NonProprietaryName>Frangula Purshiana Bark</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090114</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FRANGULA PURSHIANA BARK</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>21749-578-01</NDCCode>
<PackageDescription>30 mL in 1 PACKAGE (21749-578-01) </PackageDescription>
<NDC11Code>21749-0578-01</NDC11Code>
<ProductNDC>21749-578</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purell Advanced Hand Sanitizer Blushing Pink Orchid</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160501</StartMarketingDate>
<EndMarketingDate>20190731</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160501</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59676-578-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (59676-578-30) </PackageDescription>
<NDC11Code>59676-0578-30</NDC11Code>
<ProductNDC>59676-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prezcobix</ProprietaryName>
<NonProprietaryName>Darunavir Ethanolate And Cobicistat</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250321</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205395</ApplicationNumber>
<LabelerName>Janssen Products, LP</LabelerName>
<SubstanceName>DARUNAVIR ETHANOLATE; COBICISTAT</SubstanceName>
<StrengthNumber>675; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREZCOBIX and PREZCOBIX PED are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) [see Use in Specific Populations (8.4) and Clinical Studies (14)].</IndicationAndUsage>
<Description>PREZCOBIX and PREZCOBIX PED are fixed-dose combination products containing darunavir and cobicistat. Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family. Darunavir: Darunavir, in the form of darunavir ethanolate, has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester monoethanolate. Its molecular formula is C27H37N3O7S ∙ C2H5OH and its molecular weight is 593.73. Darunavir ethanolate has the following structural formula. Cobicistat: Cobicistat is adsorbed onto silicon dioxide. The chemical name for cobicistat is 1,3-thiazol-5-ylmethyl[(2R,5R)-5-{[(2S)2-[(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}carbamoyl)amino]-4-(morpholin-4yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate. It has a molecular formula of C40H53N7O5S2 and a molecular weight of 776.0. It has the following structural formula. PREZCOBIX® 800 mg darunavir/150 mg cobicistat tablets are for oral administration. Each tablet contains darunavir ethanolate equivalent to 800 mg of darunavir and 150 mg of cobicistat. The tablets include the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, and silicified microcrystalline cellulose. The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. PREZCOBIX® 675 mg darunavir/150 mg cobicistat tablets are for oral administration. Each tablet contains darunavir ethanolate equivalent to 675 mg of darunavir and 150 mg of cobicistat. The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. PREZCOBIX® PED 600 mg darunavir/90 mg cobicistat tablets for oral suspension are for oral administration. Each tablet for oral suspension contains darunavir ethanolate equivalent to 600 mg of darunavir and 90 mg of cobicistat. The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, silicified microcrystalline cellulose, strawberry flavor, and sucralose. The tablets are film-coated with a coating material containing glycerol monocaprylocaprate type 1, iron oxide red, iron oxide black, macrogol polyvinyl alcohol graft copolymer, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>61621-430-01</NDCCode>
<PackageDescription>1 TABLET in 1 POUCH (61621-430-01) </PackageDescription>
<NDC11Code>61621-0430-01</NDC11Code>
<ProductNDC>61621-430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dsuvia</ProprietaryName>
<NonProprietaryName>Sufentanil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20181102</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209128</ApplicationNumber>
<LabelerName>AcelRx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SUFENTANIL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181102</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting. , 2 Not for use for more than 72 hours. The use of DSUVIA beyond 72 hours has not been studied., 3 Only to be administered by a healthcare provider., 4 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, [see Warnings and Precautions (5.3)], reserve opioid analgesics, including DSUVIA, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>DSUVIA contains one 30 mcg sufentanil tablet housed in a disposable single-dose applicator (SDA). The DSUVIA tablet is an immediate release formulation intended for sublingual administration. Each tablet is blue, flat-faced with a diameter of 3 mm. The IUPAC chemical name for sufentanil is N-[4-(methoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide citrate. Sufentanil citrate has a molecular weight of 578.4 (molecular weight of free sufentanil base is 386.55), its empirical formula is C 28H 38N 2O 9S ● C 6H 8N 2O 7, and its chemical structure is shown below:. DSUVIA tablets inactive ingredients are: mannitol; dicalcium phosphate anhydrous; hypromellose; croscarmellose sodium; FD&C Blue #2; stearic acid and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>61621-430-11</NDCCode>
<PackageDescription>10 TABLET in 1 CARTON (61621-430-11) </PackageDescription>
<NDC11Code>61621-0430-11</NDC11Code>
<ProductNDC>61621-430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dsuvia</ProprietaryName>
<NonProprietaryName>Sufentanil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20181102</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209128</ApplicationNumber>
<LabelerName>AcelRx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SUFENTANIL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181102</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting. , 2 Not for use for more than 72 hours. The use of DSUVIA beyond 72 hours has not been studied., 3 Only to be administered by a healthcare provider., 4 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, [see Warnings and Precautions (5.3)], reserve opioid analgesics, including DSUVIA, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>DSUVIA contains one 30 mcg sufentanil tablet housed in a disposable single-dose applicator (SDA). The DSUVIA tablet is an immediate release formulation intended for sublingual administration. Each tablet is blue, flat-faced with a diameter of 3 mm. The IUPAC chemical name for sufentanil is N-[4-(methoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide citrate. Sufentanil citrate has a molecular weight of 578.4 (molecular weight of free sufentanil base is 386.55), its empirical formula is C 28H 38N 2O 9S ● C 6H 8N 2O 7, and its chemical structure is shown below:. DSUVIA tablets inactive ingredients are: mannitol; dicalcium phosphate anhydrous; hypromellose; croscarmellose sodium; FD&C Blue #2; stearic acid and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>63323-578-01</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-03) </PackageDescription>
<NDC11Code>63323-0578-01</NDC11Code>
<ProductNDC>63323-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20171027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209328</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anesthesia. Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. Peptic Ulcer. For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.</IndicationAndUsage>
<Description>Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains: Glycopyrrolate, 0.2 mg; water for injection, q.s.; benzyl alcohol, 0.9% (preservative); pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide.Its structural formula is as follows: C19H28BrNO3 M.W. 398.33Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol /water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
</NDC>
<NDC>
<NDCCode>63323-578-02</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-578-04) </PackageDescription>
<NDC11Code>63323-0578-02</NDC11Code>
<ProductNDC>63323-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20171027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209328</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anesthesia. Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. Peptic Ulcer. For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.</IndicationAndUsage>
<Description>Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains: Glycopyrrolate, 0.2 mg; water for injection, q.s.; benzyl alcohol, 0.9% (preservative); pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide.Its structural formula is as follows: C19H28BrNO3 M.W. 398.33Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol /water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
</NDC>
<NDC>
<NDCCode>63323-578-05</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (63323-578-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-578-07) </PackageDescription>
<NDC11Code>63323-0578-05</NDC11Code>
<ProductNDC>63323-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20171027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209328</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anesthesia. Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. Peptic Ulcer. For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.</IndicationAndUsage>
<Description>Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains: Glycopyrrolate, 0.2 mg; water for injection, q.s.; benzyl alcohol, 0.9% (preservative); pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide.Its structural formula is as follows: C19H28BrNO3 M.W. 398.33Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol /water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).</Description>
</NDC>
<NDC>
<NDCCode>70550-578-01</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (70550-578-01) / 60 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>70550-0578-01</NDC11Code>
<ProductNDC>70550-578</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Keranique Hair Regrowth Treatment For Women</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078176</ApplicationNumber>
<LabelerName>PROFECTUS BEAUTY, LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the scalp.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70550-578-02</NDCCode>
<PackageDescription>2 BOTTLE, SPRAY in 1 BOX (70550-578-02) / 60 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>70550-0578-02</NDC11Code>
<ProductNDC>70550-578</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Keranique Hair Regrowth Treatment For Women</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078176</ApplicationNumber>
<LabelerName>PROFECTUS BEAUTY, LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the scalp.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70550-578-03</NDCCode>
<PackageDescription>3 BOTTLE, SPRAY in 1 BOX (70550-578-03) / 60 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>70550-0578-03</NDC11Code>
<ProductNDC>70550-578</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Keranique Hair Regrowth Treatment For Women</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078176</ApplicationNumber>
<LabelerName>PROFECTUS BEAUTY, LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the scalp.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70550-578-04</NDCCode>
<PackageDescription>4 BOTTLE, SPRAY in 1 BOX (70550-578-04) / 60 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>70550-0578-04</NDC11Code>
<ProductNDC>70550-578</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Keranique Hair Regrowth Treatment For Women</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078176</ApplicationNumber>
<LabelerName>PROFECTUS BEAUTY, LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the scalp.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-578-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (71205-578-30) </PackageDescription>
<NDC11Code>71205-0578-30</NDC11Code>
<ProductNDC>71205-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206261</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections: Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules are formulations for oral administration. Each capsule of Acyclovir contains 200 mg of acyclovir and the inactive ingredients: lactose monohydrate, sodium lauryl sulfate, corn starch, and magnesium stearate. The capsule shell consists of FD&C Blue #1, gelatin, and titanium dioxide. The imprinting ink contains, alcohol, FD&C Blue #2, FD&C Red #40, FD&C Yellow#10, iron oxide black, shellac Glaze. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6 H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>71205-578-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (71205-578-60) </PackageDescription>
<NDC11Code>71205-0578-60</NDC11Code>
<ProductNDC>71205-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206261</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections: Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules are formulations for oral administration. Each capsule of Acyclovir contains 200 mg of acyclovir and the inactive ingredients: lactose monohydrate, sodium lauryl sulfate, corn starch, and magnesium stearate. The capsule shell consists of FD&C Blue #1, gelatin, and titanium dioxide. The imprinting ink contains, alcohol, FD&C Blue #2, FD&C Red #40, FD&C Yellow#10, iron oxide black, shellac Glaze. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6 H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>71205-578-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (71205-578-90) </PackageDescription>
<NDC11Code>71205-0578-90</NDC11Code>
<ProductNDC>71205-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206261</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections: Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules are formulations for oral administration. Each capsule of Acyclovir contains 200 mg of acyclovir and the inactive ingredients: lactose monohydrate, sodium lauryl sulfate, corn starch, and magnesium stearate. The capsule shell consists of FD&C Blue #1, gelatin, and titanium dioxide. The imprinting ink contains, alcohol, FD&C Blue #2, FD&C Red #40, FD&C Yellow#10, iron oxide black, shellac Glaze. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6 H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>71610-578-60</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-60) </PackageDescription>
<NDC11Code>71610-0578-60</NDC11Code>
<ProductNDC>71610-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206145</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate and copovidone. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>71610-578-70</NDCCode>
<PackageDescription>120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-70) </PackageDescription>
<NDC11Code>71610-0578-70</NDC11Code>
<ProductNDC>71610-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206145</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate and copovidone. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>71610-578-80</NDCCode>
<PackageDescription>180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-80) </PackageDescription>
<NDC11Code>71610-0578-80</NDC11Code>
<ProductNDC>71610-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206145</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate and copovidone. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>71610-578-94</NDCCode>
<PackageDescription>360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-94) </PackageDescription>
<NDC11Code>71610-0578-94</NDC11Code>
<ProductNDC>71610-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206145</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients corn starch, povidone and magnesium stearate. In addition, the coating for each tablet contains hypromellose, talc, titanium dioxide, polyethylene glycol, and propylene glycol. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate and copovidone. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>72603-578-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72603-578-01) / 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72603-0578-01</NDC11Code>
<ProductNDC>72603-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201404</ApplicationNumber>
<LabelerName>NorthStar Rx, LLC</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin for intravenous use. The pharmacy bulk package contains sterile ampicillin sodium equivalent to 10 grams ampicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Grampositive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates.A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package). It has the following molecular structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10. The pH range of the reconstituted solution is 8 to 10. Ampicillin for Injection, USP contains 65.83 mg (2.86 milliequivalents) of sodium per 1 gram of drug. Ampicillin for Injection, USP is white to off-white crystalline powder. The solution after reconstitution is clear and colorless. Each Ampicillin for Injection Pharmacy Bulk Package bottle contains ampicillin sodium equivalent to 10 grams of ampicillin.</Description>
</NDC>
<NDC>
<NDCCode>72789-578-20</NDCCode>
<PackageDescription>20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-578-20) </PackageDescription>
<NDC11Code>72789-0578-20</NDC11Code>
<ProductNDC>72789-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077863</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
<Description>Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>72789-578-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-578-30) </PackageDescription>
<NDC11Code>72789-0578-30</NDC11Code>
<ProductNDC>72789-578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077863</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
<Description>Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>71655-103-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (71655-103-01) / 34 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>71655-0103-01</NDC11Code>
<ProductNDC>71655-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Raxibacumab</ProprietaryName>
<NonProprietaryName>Raxibacumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20121214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125349</ApplicationNumber>
<LabelerName>Emergent BioDefense Operations Lansing</LabelerName>
<SubstanceName>RAXIBACUMAB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthrax Protective Antigen-directed Antibody Interactions [MoA], Anthrax Protective Antigen-directed Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracisin combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ( 1.1). Limitations of Use: 1 The effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. ( 1.2, 14.1) , 2 There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using an extrapolation approach. ( 1.2, 8.4) , 3 Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis. Raxibacumab should be used in combination with appropriate antibacterial drugs. ( 1.2) .</IndicationAndUsage>
<Description>Raxibacumab is a human IgG1λ monoclonal antibody that binds the PA component of B. anthracistoxin. Raxibacumab has a molecular weight of approximately 146 kilodaltons. Raxibacumab is produced by recombinant DNA technology in a murine cell expression system. Raxibacumab is supplied as a sterile, preservative-free, clear to opalescent, colorless to pale yellow liquid formulation in single-use vials for intravenous infusion. Each vial contains 1,700 mg/34 mL (50 mg/mL) raxibacumab in citric acid (0.13 mg/mL), glycine (18 mg/mL), polysorbate 80 [0.2 mg/mL (w/v)], sodium citrate (2.8 mg/mL), sucrose (10 mg/mL), and Water for Injection, with a pH of 6.5.</Description>
</NDC>
<NDC>
<NDCCode>0173-0956-76</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (0173-0956-76) / 8 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00173-0956-76</NDC11Code>
<ProductNDC>0173-0956</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Utebzi</ProprietaryName>
<NonProprietaryName>Tebipenem Pivoxil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215960</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>TEBIPENEM PIVOXIL HYDROBROMIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UTEBZI is a penem antibacterial indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis in adult patients who have limited or no alternative oral treatment options. (1.1). Usage to Reduce Development of Drug‑Resistant Bacteria. To reduce the development of drug‑resistant bacteria and maintain the effectiveness of UTEBZI and other antibacterial drugs, UTEBZI should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.2).</IndicationAndUsage>
<Description>UTEBZI (tebipenem pivoxil) tablets, for oral use, contain tebipenem pivoxil hydrobromide, the hydrobromide salt of tebipenem pivoxil, a prodrug of tebipenem, a carbapenem antibacterial. The chemical name is (pivaloyloxy)methyl (4R,5S,6S)-3-((1-(4,5-dihydrothiazol-2-yl)azetidin-3-yl)thio)-6-((R)-1-hydroxyethyl)-4-methyl-7-oxo-1-azabicylo[3.2.0]hept-2-ene-2-carboxylate hydrobromide. The empirical formula is C22H32BrN3O6S2 and the molecular weight is 578.54 g/mol. The structural formula of tebipenem pivoxil hydrobromide is shown below. Tebipenem pivoxil hydrobromide is a white to off-white powder and is sparingly soluble in water. Each film‑coated UTEBZI tablet contains 300 mg tebipenem pivoxil, present as 348.8 mg tebipenem pivoxil hydrobromide and the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The tablet film‑coating consists of FD&C blue 1, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0409-3382-21</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3382-21) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-3382-11) </PackageDescription>
<NDC11Code>00409-3382-21</NDC11Code>
<ProductNDC>0409-3382</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sufentanil Citrate</ProprietaryName>
<NonProprietaryName>Sufentanil Citrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20050726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074534</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SUFENTANIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients: 1 as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated., 2 as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.</IndicationAndUsage>
<Description>Sufentanil Citrate Injection, USP is a sterile, nonpyrogenic solution of sufentanil citrate in water for injection. Sufentanil Citrate is a potent opioid analgesic which is administered either epidurally or by intravenous injection. Each mL contains sufentanil citrate equivalent to 50 mcg of sufentanil. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 4.2 (3.5 to 6.0). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-use injection. When smaller doses are required, the unused portion should be discarded in an appropriate manner. Sufentanil Citrate, USP, occurs as a white crystalline powder and is chemically designated as N-[-4-(methyoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The molecular formula of sufentanil citrate is C22H30N2O2S∙C6H8O7 and the molecular weight is 578.69. Sufentanil Citrate has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0519-8802-13</NDCCode>
<PackageDescription>444 mL in 1 BOTTLE, PLASTIC (0519-8802-13) </PackageDescription>
<NDC11Code>00519-8802-13</NDC11Code>
<ProductNDC>0519-8802</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140908</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Steris Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>578</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Healthcare Personnel Handwash to decrease bacteria on the skin before contact with patients under medical care or treatment.</IndicationAndUsage>
</NDC>
</NDCList>