{
"NDC": [
{
"NDCCode": "72888-142-22",
"PackageDescription": "1 BOTTLE in 1 CARTON (72888-142-22) / 5 mL in 1 BOTTLE",
"NDC11Code": "72888-0142-22",
"ProductNDC": "72888-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078282",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220222",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms. Gram-positive bacteria. Corynebacterium species*. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumonia. Streptococcus(Groups C/F). Streptococcus(Group G). Viridans group streptococci*. Gram-negative bacteria. Acinetobacter lwoffii *. Haemophilus influenzae. Serratia marcescens*. *Efficacy for this organism was studied in fewer than 10 infections.",
"Description": "Levofloxacin Ophthalmic Solution, 0.5% is a sterile topical ophthalmic solution. Levofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens. Levofloxacin is a fluorinated 4-quinolone containing a six-member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure. Levofloxacin is the pure (-)-(S)-enantiomer of the racemic drug substance, ofloxacin. It is more soluble in water at neutral pH than ofloxacin. Chemical Name: (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate. Levofloxacin (hemihydrate) is a light yellow powder. Each mL of levofloxacin ophthalmic solution, 0.5% contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg levofloxacin. Contains Levofloxacin 5 mg equivalent to 5.12 mg levofloxacin hemihydrate with benzalkonium chloride 0.005%, sodium chloride, water for injection, hydrochloric acid and/or sodium hydroxide (to adjust pH). Levofloxacin ophthalmic solution, 0.5% is isotonic and formulated at pH 6.0-6.8 with an osmolality between 285-315 mOsm/kg."
},
{
"NDCCode": "72888-102-22",
"PackageDescription": "5 mL in 1 BOTTLE (72888-102-22) ",
"NDC11Code": "72888-0102-22",
"ProductNDC": "72888-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin Hydrochloride",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075928",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2025-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220316",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Corneal Ulcers: Pseudomonas aeruginosa. Serratia marcescens*. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumoniae. Streptococcus(Viridans Group) *. Conjunctivitis: Haemophilus influenzae. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumoniae. *Efficacy for this organism was studied in fewer than 10 infections.",
"Description": "Ciprofloxacin ophthalmic solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HCLH 2O and its chemical structure is as follows:. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of ciprofloxacin ophthalmic solution contains. Active:Ciprofloxacin hydrochloride 3.5 mg equivalent to 3mg base. Preservative:Benzalkonium chloride 0.006%. Inactives:Acetic acid, edetate disodium 0.05%, mannitol 4.6%, Sodium acetate, hydrochloric acid and/or sodium hydroxide (to adjust pH) and water for injection. The pH is between 3.5 to 5.5 and the osmolality is between 290 to 300 mOsms/kg."
},
{
"NDCCode": "72888-150-22",
"PackageDescription": "1 BOTTLE in 1 CARTON (72888-150-22) / 5 mL in 1 BOTTLE",
"NDC11Code": "72888-0150-22",
"ProductNDC": "72888-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077600",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac Sodium Ophthalmic is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.",
"Description": "Diclofenac sodium ophthalmic solution, 0.1% is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. Diclofenac sodium is designated chemically as 2-[(2,6 dichlorophenyl) amino] benzeneacetic acid, monosodium salt, with an empirical formula of C 14H 10C l2NO 2Na. The structural formula of diclofenac sodium is:. Diclofenac sodium ophthalmic solution is available as a sterile solution, which contains diclofenac sodium 0.1%(1mg/mL). Inactive Ingredients:polyoxyl 35 castor oil, Boric acid, tromethamine, sorbic acid (2 mg/mL), edetate disodium (1 mg/mL), and purified water. Diclofenac sodium is a faintly yellow-white to light beige, slightly hygroscopic crystalline powder. It is freely soluble in methanol, sparingly soluble in water, very slightly soluble in acetonitrile, and insoluble in chloroform and in 0.1N hydrochloric acid. Its molecular weight is 318.14. Diclofenac sodium ophthalmic solution, 0.1% is a clear, colourless solution with an osmolality between 270 mOsmols/kg to 310 mOsmols/kg, buffered at a pH between 6.0 to 8.0. Diclofenac sodium ophthalmic solution has a faint characteristic odor of castor oil."
},
{
"NDCCode": "15408-002-22",
"PackageDescription": "142 L in 1 CYLINDER (15408-002-22)",
"NDC11Code": "15408-0002-22",
"ProductNDC": "15408-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Westair Gas & Equipment, LLC",
"SubstanceName": "NITROGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49972-002-22",
"PackageDescription": "142 L in 1 CYLINDER (49972-002-22)",
"NDC11Code": "49972-0002-22",
"ProductNDC": "49972-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Praxair Distribution Southeast LLC",
"SubstanceName": "NITROGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "59579-002-22",
"PackageDescription": "142 L in 1 CYLINDER (59579-002-22) ",
"NDC11Code": "59579-0002-22",
"ProductNDC": "59579-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205850",
"LabelerName": "Linde Gas & Equipment Inc.",
"SubstanceName": "NITROGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071001",
"SamplePackage": "N"
},
{
"NDCCode": "73468-003-22",
"PackageDescription": "142 L in 1 CYLINDER (73468-003-22) ",
"NDC11Code": "73468-0003-22",
"ProductNDC": "73468-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20191210",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205766",
"LabelerName": "Magnegas Welding Supply-South, LLC",
"SubstanceName": "NITROGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2023-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20191210",
"SamplePackage": "N"
},
{
"NDCCode": "76133-002-22",
"PackageDescription": "142 L in 1 CYLINDER (76133-002-22)",
"NDC11Code": "76133-0002-22",
"ProductNDC": "76133-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Praxair Distribution Mid-atlantic, Llc",
"SubstanceName": "NITROGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "72888-077-15",
"PackageDescription": "1 BOTTLE in 1 CARTON (72888-077-15) / 10 mL in 1 BOTTLE",
"NDC11Code": "72888-0077-15",
"ProductNDC": "72888-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hydrochloride",
"NonProprietaryName": "Dorzolamide Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20241223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078395",
"LabelerName": "Advagen Pharma Ltd.",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241223",
"SamplePackage": "N",
"Description": "Dorzolamide hydrochloride ophthalmic solution is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Dorzolamide hydrochloride is described chemically as: (4 S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4 H-thieno[2,3- b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is. Its empirical formula is C 10H 16N 2O 4S 3HCl and its structural formula is:. Dorzolamide hydrochloride has a molecular weight of 360.9 and a melting point of about 264°C. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Dorzolamide hydrochloride ophthalmic solution is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride. The pH of the solution is approximately 5.4 to 5.9, and the osmolarity is 260-330 mOsmoles/kg. Each mL of dorzolamide hydrochloride ophthalmic solution 2% contains 20 mg dorzolamide (equivalent to 22.3 mg of dorzolamide hydrochloride). Inactive ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide (to adjust pH) and water for injection. Benzalkonium chloride 0.0075% is added as a preservative."
},
{
"NDCCode": "72888-206-09",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (72888-206-09) / 10 TABLET in 1 BLISTER PACK (72888-206-08) ",
"NDC11Code": "72888-0206-09",
"ProductNDC": "72888-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivermectin",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215922",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250122",
"SamplePackage": "N",
"IndicationAndUsage": "Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.",
"Description": "Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "72888-206-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (72888-206-30) ",
"NDC11Code": "72888-0206-30",
"ProductNDC": "72888-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivermectin",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215922",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250122",
"SamplePackage": "N",
"IndicationAndUsage": "Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.",
"Description": "Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "72888-206-66",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (72888-206-66) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "72888-0206-66",
"ProductNDC": "72888-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivermectin",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215922",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250122",
"SamplePackage": "N",
"IndicationAndUsage": "Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.",
"Description": "Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "72888-207-09",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (72888-207-09) / 10 TABLET in 1 BLISTER PACK (72888-207-08) ",
"NDC11Code": "72888-0207-09",
"ProductNDC": "72888-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivermectin",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215922",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250122",
"SamplePackage": "N",
"IndicationAndUsage": "Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.",
"Description": "Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "72888-207-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (72888-207-30) ",
"NDC11Code": "72888-0207-30",
"ProductNDC": "72888-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivermectin",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215922",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250122",
"SamplePackage": "N",
"IndicationAndUsage": "Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.",
"Description": "Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "72888-207-66",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (72888-207-66) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "72888-0207-66",
"ProductNDC": "72888-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivermectin",
"NonProprietaryName": "Ivermectin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215922",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "IVERMECTIN",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiparasitic [EPC], Pediculicide [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250122",
"SamplePackage": "N",
"IndicationAndUsage": "Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.",
"Description": "Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "0004-0381-40",
"PackageDescription": "1 KIT in 1 CARTON (0004-0381-40) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00004-0381-40",
"ProductNDC": "0004-0381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fuzeon",
"NonProprietaryName": "Enfuvirtide",
"DosageFormName": "KIT",
"StartMarketingDate": "20120410",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021481",
"LabelerName": "Genentech, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120410",
"SamplePackage": "N",
"IndicationAndUsage": "FUZEON® in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.",
"Description": "FUZEON (enfuvirtide) is an inhibitor of the fusion of HIV-1 with CD4 cells. Enfuvirtide is a linear 36-amino acid synthetic peptide with the N-terminus acetylated and the C-terminus is a carboxamide. It is composed of naturally occurring L-amino acid residues. Enfuvirtide is a white to off-white amorphous solid. It has negligible solubility in pure water and the solubility increases in aqueous buffers (pH 7.5) to 85-142 g/100 mL. The empirical formula of enfuvirtide is C204H301N51O64, and the molecular weight is 4492. It has the following primary amino acid sequence. CH3CO-Tyr-Thr-Ser-Leu-Ile-His-Ser-Leu-Ile-Glu-Glu-Ser-Gln-Asn-Gln-Gln-Glu-Lys-Asn-Glu-Gln-Glu-Leu-Leu-Glu-Leu-Asp-Lys-Trp-Ala-Ser-Leu-Trp-Asn-Trp-Phe-NH2 and the following structural formula. The drug product, FUZEON (enfuvirtide) for Injection, is a white to off-white, sterile, lyophilized powder. Each single-dose vial contains 108 mg of enfuvirtide for the delivery of 90 mg. Prior to subcutaneous administration, the contents of the vial are reconstituted with 1 mL of Sterile Water for Injection to provide the delivery of 1 mL of the solution. Each 1 mL of the reconstituted solution contains approximately 90 mg of enfuvirtide with approximate amounts of the following excipients: 22.55 mg of mannitol, 2.39 mg of sodium carbonate (anhydrous), and sodium hydroxide and hydrochloric acid for pH adjustment as needed. The reconstituted solution has an approximate pH of 9.0."
},
{
"NDCCode": "0295-1110-21",
"PackageDescription": "1 TUBE in 1 CARTON (0295-1110-21) > 142 g in 1 TUBE",
"NDC11Code": "00295-1110-21",
"ProductNDC": "0295-1110",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunburnt Plus Pain Relief",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180315",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Denison Pharmaceuticals, LLC.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180315",
"SamplePackage": "N"
},
{
"NDCCode": "10572-101-01",
"PackageDescription": "4 L in 1 JUG (10572-101-01) ",
"NDC11Code": "10572-0101-01",
"ProductNDC": "10572-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Peg-3350 And Electrolytes",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"EndMarketingDate": "20240229",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019011",
"LabelerName": "Affordable Pharmaceuticals, LLC",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS",
"StrengthNumber": "236; 2.97; 6.74; 5.86; 22.74",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090701",
"EndMarketingDatePackage": "20240229",
"SamplePackage": "N",
"IndicationAndUsage": "PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.",
"Description": "PEG-3350 and Electrolytes for Oral Solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na 2SO 4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO 3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na + Cl -. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
},
{
"NDCCode": "10695-142-10",
"PackageDescription": "1 kg in 1 CONTAINER (10695-142-10) ",
"NDC11Code": "10695-0142-10",
"ProductNDC": "10695-142",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Maropitant Citrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20221209",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Willow Birch Pharma, Inc.",
"SubstanceName": "MAROPITANT CITRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "09-DEC-22"
},
{
"NDCCode": "17156-023-05",
"PackageDescription": "1 KIT in 1 CARTON (17156-023-05) * 5 VIAL in 1 TRAY / 1 mL in 1 VIAL * 5 VIAL in 1 TRAY / 4.5 mL in 1 VIAL * 5 VIAL in 1 TRAY (17156-022-05) / 5 mL in 1 VIAL",
"NDC11Code": "17156-0023-05",
"ProductNDC": "17156-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ceretec",
"NonProprietaryName": "Exametazime",
"DosageFormName": "KIT",
"StartMarketingDate": "19881230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019829",
"LabelerName": "Medi-Physics Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-02-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19881230",
"SamplePackage": "N",
"IndicationAndUsage": "Technetium Tc99m exametazime scintigraphy (with or without methylene blue stabilization) may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. Tc99m exametazime without methylene blue stabilization is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.",
"Description": "The Ceretec kit is supplied as five packs of three vials for use in the preparation of a technetium Tc99m exametazime intravenous injection as a diagnostic radiopharmaceutical for use as an adjunct in the detection of altered regional cerebral perfusion and for the radiolabeling of autologous leukocytes. Each vial of Ceretec contains a pre-dispensed sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime [(RR,SS)-4.8-diaza-3,6,6,9-tetramethylundecane-2, 10-dione bisoxime], 7.6 µg stannous chloride dihydrate (minimum stannous tin 0.6 µg; maximum total stannous and stannic tin 4.0 µg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative. In addition, each package contains five 1 mL vials of Methylene Blue Injection USP 1% containing 10 mg methylene blue USP in Water for Injection q.s. pH adjusted with sodium hydroxide and/or hydrochloric acid, when necessary. Methylene Blue Injection USP is a sterile, non-pyrogenic solution of phenothiazin-5-ium,3,7-bis (dimethylamino)-chloride, trihydrate. Each package also contains five 4.5 mL vials of 0.003 M Monobasic Sodium Phosphate USP and Dibasic Sodium Phosphate USP in 0.9% Sodium Chloride Injection USP. The solution is sterile and non-pyrogenic. Each mL contains 0.276 mg monobasic sodium phosphate monohydrate (equivalent to 0.312 mg monobasic sodium phosphate dihydrate), 0.142 mg dibasic sodium phosphate anhydrous (equivalent to 0.178 mg dibasic sodium phosphate dihydrate) and 9 mg sodium chloride in Water for Injection q.s. The total calculated osmolarity of the 0.003 M Monobasic Sodium Phosphate USP and Dibasic Sodium Phosphate USP in 0.9% Sodium Chloride Injection USP is 317 mOsmol/L. Each mL provides 0.285 mg (3mM) of phosphate, 0.157 mEq of sodium and 0.154 mEq of chloride. When used according to the preparation instructions (see DOSAGE AND ADMINISTRATION), Methylene Blue Sodium Phosphates/Sodium Chloride mixture acts as a stabilizer. Prior to publication of the USAN, exametazime was formerly known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications. The structural formula of exametazime is. When sterile pyrogen-free sodium pertechnetate Tc99m in isotonic saline is added to the vial of Ceretec, a Tc99m complex of exametazime is formed. Administration is by intravenous injection for diagnostic use."
},
{
"NDCCode": "22607-142-20",
"PackageDescription": "10 VIAL in 1 CARTON (22607-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "22607-0142-20",
"ProductNDC": "22607-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"NonProprietaryName": "Ampicillin And Sulbactam",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"StartMarketingDate": "20091222",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Mitim S.r.L.",
"SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
"StrengthNumber": "1; .5",
"StrengthUnit": "g/1; g/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "22-DEC-09"
},
{
"NDCCode": "24338-236-01",
"PackageDescription": "4 L in 1 BOTTLE, PLASTIC (24338-236-01) ",
"NDC11Code": "24338-0236-01",
"ProductNDC": "24338-236",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Golytely",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260417",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019011",
"LabelerName": "Azurity Pharmaceuticals, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "236; 22.74; 6.74; 5.86; 2.97",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260417",
"SamplePackage": "N",
"IndicationAndUsage": "GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.",
"Description": "GoLYTELY is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
},
{
"NDCCode": "25021-142-20",
"PackageDescription": "10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "25021-0142-20",
"ProductNDC": "25021-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin And Sulbactam",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20100630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201406",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
"StrengthNumber": "1; .5",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100630",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin and Sulbactam for Injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,2 Klebsiella spp.2 (including K. pneumoniae2), Proteus mirabilis,2 Bacteroides fragilis,2 Enterobacter spp.,2 and Acinetobacter calcoaceticus.2. NOTE: For information on use in pediatric patients (see PRECAUTIONS–Pediatric Use and CLINICAL STUDIES sections). Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae2), Bacteroides spp. (including B. fragilis), and Enterobacter spp.2. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,2 and Bacteroides spp.2 (including B. fragilis2). _________. 2Efficacy for this organism in this organ system was studied in fewer than 10 infections. While Ampicillin and Sulbactam for Injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection and other antibacterial drugs, Ampicillin and Sulbactam for Injection should be used only to treat 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.",
"Description": "Ampicillin and Sulbactam for Injection, USP is a sterile antibacterial fixed-combination drug product consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is:. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is:. Ampicillin and Sulbactam for Injection, USP is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Each 1.5 g vial contains ampicillin 1 g and sulbactam 0.5 g (equivalent to 1.063 g ampicillin sodium and 0.547 g sulbactam sodium). Each 1.5 g vial contains approximately 115 mg of sodium. Each 3 g vial contains ampicillin 2 g and sulbactam 1 g (equivalent to 2.125 g ampicillin sodium and 1.094 g sulbactam sodium). Each 3 g vial contains approximately 230 mg of sodium."
},
{
"NDCCode": "33342-546-53",
"PackageDescription": "2 BOTTLE in 1 CARTON (33342-546-53) / 177 mL in 1 BOTTLE (33342-546-23) ",
"NDC11Code": "33342-0546-53",
"ProductNDC": "33342-546",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral",
"NonProprietaryName": "Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219429",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE",
"StrengthNumber": "17.5; 3.13; 1.6",
"StrengthUnit": "g/177mL; g/177mL; g/177mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult Patient. \"Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREPBOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.\".",
"Description": "Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: citric acid monohydrate USP, malic acid USP, purified water, raspberry flavour, sodium benzoate USP, sucralose USP. Sodium Sulfate Anhydrous USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Potassium Sulfate, FCC The chemical name is K2SO4. The average Molecular Weight is 174.26. The structural formula is. Magnesium Sulfate Heptahydrate USP The chemical name is MgSO4. The average Molecular Weight: 120.37. The structural formula is. Each Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution also contains a polypropylene mixing container. \"Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREPBOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.\"."
},
{
"NDCCode": "40032-090-19",
"PackageDescription": "274.31 g in 1 BOTTLE (40032-090-19) ",
"NDC11Code": "40032-0090-19",
"ProductNDC": "40032-090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol-3350 And Electrolytes",
"NonProprietaryName": "Polyethylene Glycol-3350 And Electrolytes",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090231",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "236; 22.74; 6.74; 5.86; 2.97",
"StrengthUnit": "g/274.31g; g/274.31g; g/274.31g; g/274.31g; g/274.31g",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2023-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090601",
"SamplePackage": "N",
"IndicationAndUsage": "PEG-3350 and electrolytes for oral solution, USP is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults (1).",
"Description": "PEG-3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white to off-white powder. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
},
{
"NDCCode": "43386-090-19",
"PackageDescription": "274.31 g in 1 BOTTLE (43386-090-19) ",
"NDC11Code": "43386-0090-19",
"ProductNDC": "43386-090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gavilyte G",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Polyethylene Glycol-3350 And Electrolytes",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090231",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "236; 22.74; 6.74; 5.86; 2.97",
"StrengthUnit": "g/274.31g; g/274.31g; g/274.31g; g/274.31g; g/274.31g",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090601",
"SamplePackage": "N",
"IndicationAndUsage": "GaviLyte-G is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (1).",
"Description": "Gavilyte-G is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white to off-white powder. Polyethylene Glycol 3350, NF. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
},
{
"NDCCode": "43386-090-91",
"PackageDescription": "274.31 g in 1 BOTTLE (43386-090-91)",
"NDC11Code": "43386-0090-91",
"ProductNDC": "43386-090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gavilyte G",
"ProprietaryNameSuffix": "Tm",
"NonProprietaryName": "Polyethylene Glycol-3350 And Electrolytes",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090231",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "236; 22.74; 6.74; 5.86; 2.97",
"StrengthUnit": "g/274.31g; g/274.31g; g/274.31g; g/274.31g; g/274.31g",
"Pharm_Classes": "Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "GaviLyte-G is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults (1).",
"Description": "For oral solution: Each 4 liter (4L) GaviLyte-G jug contains a white powder for reconstitution. GaviLyte-G is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Each 4 liter jug contains: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, NF. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
},
{
"NDCCode": "50090-6521-0",
"PackageDescription": "4 L in 1 JUG (50090-6521-0) ",
"NDC11Code": "50090-6521-00",
"ProductNDC": "50090-6521",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Peg-3350 And Electrolytes",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019011",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "236; 22.74; 6.74; 5.86; 2.97",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2023-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230613",
"SamplePackage": "N",
"IndicationAndUsage": "PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.",
"Description": "PEG-3350 and Electrolytes for Oral Solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na 2SO 4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO 3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na + Cl -. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
},
{
"NDCCode": "50090-8020-0",
"PackageDescription": "4 L in 1 JUG (50090-8020-0) ",
"NDC11Code": "50090-8020-00",
"ProductNDC": "50090-8020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Peg",
"ProprietaryNameSuffix": "3350 And Electrolytes",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019011",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "236; 22.74; 6.74; 5.86; 2.97",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260722",
"SamplePackage": "N",
"IndicationAndUsage": "PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.",
"Description": "PEG-3350 and Electrolytes for Oral Solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
},
{
"NDCCode": "52268-101-01",
"PackageDescription": "4 L in 1 BOTTLE, PLASTIC (52268-101-01) ",
"NDC11Code": "52268-0101-01",
"ProductNDC": "52268-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Golytely",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19840713",
"EndMarketingDate": "20221031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019011",
"LabelerName": "Braintree Laboratories, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS",
"StrengthNumber": "236; 2.97; 6.74; 5.86; 22.74",
"StrengthUnit": "g/4L; g/4L; g/4L; g/4L; g/4L",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19840713",
"EndMarketingDatePackage": "20221031",
"SamplePackage": "N",
"IndicationAndUsage": "GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.",
"Description": "GoLYTELY is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na 2SO 4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO 3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na + Cl -. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
}
]
}
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<NDC>
<NDCCode>72888-142-22</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72888-142-22) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72888-0142-22</NDC11Code>
<ProductNDC>72888-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms. Gram-positive bacteria. Corynebacterium species*. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumonia. Streptococcus(Groups C/F). Streptococcus(Group G). Viridans group streptococci*. Gram-negative bacteria. Acinetobacter lwoffii *. Haemophilus influenzae. Serratia marcescens*. *Efficacy for this organism was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>Levofloxacin Ophthalmic Solution, 0.5% is a sterile topical ophthalmic solution. Levofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens. Levofloxacin is a fluorinated 4-quinolone containing a six-member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure. Levofloxacin is the pure (-)-(S)-enantiomer of the racemic drug substance, ofloxacin. It is more soluble in water at neutral pH than ofloxacin. Chemical Name: (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate. Levofloxacin (hemihydrate) is a light yellow powder. Each mL of levofloxacin ophthalmic solution, 0.5% contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg levofloxacin. Contains Levofloxacin 5 mg equivalent to 5.12 mg levofloxacin hemihydrate with benzalkonium chloride 0.005%, sodium chloride, water for injection, hydrochloric acid and/or sodium hydroxide (to adjust pH). Levofloxacin ophthalmic solution, 0.5% is isotonic and formulated at pH 6.0-6.8 with an osmolality between 285-315 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>72888-102-22</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE (72888-102-22) </PackageDescription>
<NDC11Code>72888-0102-22</NDC11Code>
<ProductNDC>72888-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin Hydrochloride</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075928</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Corneal Ulcers: Pseudomonas aeruginosa. Serratia marcescens*. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumoniae. Streptococcus(Viridans Group) *. Conjunctivitis: Haemophilus influenzae. Staphylococcus aureus. Staphylococcus epidermidis. Streptococcus pneumoniae. *Efficacy for this organism was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>Ciprofloxacin ophthalmic solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HCLH 2O and its chemical structure is as follows:. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of ciprofloxacin ophthalmic solution contains. Active:Ciprofloxacin hydrochloride 3.5 mg equivalent to 3mg base. Preservative:Benzalkonium chloride 0.006%. Inactives:Acetic acid, edetate disodium 0.05%, mannitol 4.6%, Sodium acetate, hydrochloric acid and/or sodium hydroxide (to adjust pH) and water for injection. The pH is between 3.5 to 5.5 and the osmolality is between 290 to 300 mOsms/kg.</Description>
</NDC>
<NDC>
<NDCCode>72888-150-22</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72888-150-22) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72888-0150-22</NDC11Code>
<ProductNDC>72888-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20250430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077600</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</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>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac Sodium Ophthalmic is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.</IndicationAndUsage>
<Description>Diclofenac sodium ophthalmic solution, 0.1% is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. Diclofenac sodium is designated chemically as 2-[(2,6 dichlorophenyl) amino] benzeneacetic acid, monosodium salt, with an empirical formula of C 14H 10C l2NO 2Na. The structural formula of diclofenac sodium is:. Diclofenac sodium ophthalmic solution is available as a sterile solution, which contains diclofenac sodium 0.1%(1mg/mL). Inactive Ingredients:polyoxyl 35 castor oil, Boric acid, tromethamine, sorbic acid (2 mg/mL), edetate disodium (1 mg/mL), and purified water. Diclofenac sodium is a faintly yellow-white to light beige, slightly hygroscopic crystalline powder. It is freely soluble in methanol, sparingly soluble in water, very slightly soluble in acetonitrile, and insoluble in chloroform and in 0.1N hydrochloric acid. Its molecular weight is 318.14. Diclofenac sodium ophthalmic solution, 0.1% is a clear, colourless solution with an osmolality between 270 mOsmols/kg to 310 mOsmols/kg, buffered at a pH between 6.0 to 8.0. Diclofenac sodium ophthalmic solution has a faint characteristic odor of castor oil.</Description>
</NDC>
<NDC>
<NDCCode>15408-002-22</NDCCode>
<PackageDescription>142 L in 1 CYLINDER (15408-002-22)</PackageDescription>
<NDC11Code>15408-0002-22</NDC11Code>
<ProductNDC>15408-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Westair Gas & Equipment, LLC</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49972-002-22</NDCCode>
<PackageDescription>142 L in 1 CYLINDER (49972-002-22)</PackageDescription>
<NDC11Code>49972-0002-22</NDC11Code>
<ProductNDC>49972-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Praxair Distribution Southeast LLC</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59579-002-22</NDCCode>
<PackageDescription>142 L in 1 CYLINDER (59579-002-22) </PackageDescription>
<NDC11Code>59579-0002-22</NDC11Code>
<ProductNDC>59579-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205850</ApplicationNumber>
<LabelerName>Linde Gas & Equipment Inc.</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73468-003-22</NDCCode>
<PackageDescription>142 L in 1 CYLINDER (73468-003-22) </PackageDescription>
<NDC11Code>73468-0003-22</NDC11Code>
<ProductNDC>73468-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20191210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205766</ApplicationNumber>
<LabelerName>Magnegas Welding Supply-South, LLC</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76133-002-22</NDCCode>
<PackageDescription>142 L in 1 CYLINDER (76133-002-22)</PackageDescription>
<NDC11Code>76133-0002-22</NDC11Code>
<ProductNDC>76133-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Praxair Distribution Mid-atlantic, Llc</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>72888-077-15</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72888-077-15) / 10 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72888-0077-15</NDC11Code>
<ProductNDC>72888-077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride</ProprietaryName>
<NonProprietaryName>Dorzolamide Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20241223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078395</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd.</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Dorzolamide hydrochloride ophthalmic solution is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Dorzolamide hydrochloride is described chemically as: (4 S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4 H-thieno[2,3- b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is. Its empirical formula is C 10H 16N 2O 4S 3HCl and its structural formula is:. Dorzolamide hydrochloride has a molecular weight of 360.9 and a melting point of about 264°C. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Dorzolamide hydrochloride ophthalmic solution is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride. The pH of the solution is approximately 5.4 to 5.9, and the osmolarity is 260-330 mOsmoles/kg. Each mL of dorzolamide hydrochloride ophthalmic solution 2% contains 20 mg dorzolamide (equivalent to 22.3 mg of dorzolamide hydrochloride). Inactive ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide (to adjust pH) and water for injection. Benzalkonium chloride 0.0075% is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>72888-206-09</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (72888-206-09) / 10 TABLET in 1 BLISTER PACK (72888-206-08) </PackageDescription>
<NDC11Code>72888-0206-09</NDC11Code>
<ProductNDC>72888-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivermectin</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215922</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.</IndicationAndUsage>
<Description>Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72888-206-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72888-206-30) </PackageDescription>
<NDC11Code>72888-0206-30</NDC11Code>
<ProductNDC>72888-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivermectin</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215922</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.</IndicationAndUsage>
<Description>Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72888-206-66</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (72888-206-66) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>72888-0206-66</NDC11Code>
<ProductNDC>72888-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivermectin</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215922</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.</IndicationAndUsage>
<Description>Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72888-207-09</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (72888-207-09) / 10 TABLET in 1 BLISTER PACK (72888-207-08) </PackageDescription>
<NDC11Code>72888-0207-09</NDC11Code>
<ProductNDC>72888-207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivermectin</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215922</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.</IndicationAndUsage>
<Description>Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72888-207-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72888-207-30) </PackageDescription>
<NDC11Code>72888-0207-30</NDC11Code>
<ProductNDC>72888-207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivermectin</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215922</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.</IndicationAndUsage>
<Description>Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72888-207-66</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (72888-207-66) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>72888-0207-66</NDC11Code>
<ProductNDC>72888-207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivermectin</ProprietaryName>
<NonProprietaryName>Ivermectin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215922</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>IVERMECTIN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiparasitic [EPC], Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivermectin tablets are indicated for the treatment of the following infections. Strongyloidiasis of the intestinal tract. Ivermectin tablet is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY, Clinical Studies.). Onchocerciasis. Ivermectin tablet is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin tablet has no activity against adult Onchocerca volvulusparasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.</IndicationAndUsage>
<Description>Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis. Ivermectin is a mixture containing at least 90% 5- O-demethyl-22,23-dihydroavermectin A 1aand less than 10% 5- Odemethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a, generally referred to as 22,23- dihydroavermectin B 1aand B 1b, or H 2B 1aand H 2B 1b, respectively. The respective empirical formulas are C 48H 74O 14and C 47H 72O 14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:. Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0004-0381-40</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0004-0381-40) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00004-0381-40</NDC11Code>
<ProductNDC>0004-0381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fuzeon</ProprietaryName>
<NonProprietaryName>Enfuvirtide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120410</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021481</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FUZEON® in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.</IndicationAndUsage>
<Description>FUZEON (enfuvirtide) is an inhibitor of the fusion of HIV-1 with CD4 cells. Enfuvirtide is a linear 36-amino acid synthetic peptide with the N-terminus acetylated and the C-terminus is a carboxamide. It is composed of naturally occurring L-amino acid residues. Enfuvirtide is a white to off-white amorphous solid. It has negligible solubility in pure water and the solubility increases in aqueous buffers (pH 7.5) to 85-142 g/100 mL. The empirical formula of enfuvirtide is C204H301N51O64, and the molecular weight is 4492. It has the following primary amino acid sequence. CH3CO-Tyr-Thr-Ser-Leu-Ile-His-Ser-Leu-Ile-Glu-Glu-Ser-Gln-Asn-Gln-Gln-Glu-Lys-Asn-Glu-Gln-Glu-Leu-Leu-Glu-Leu-Asp-Lys-Trp-Ala-Ser-Leu-Trp-Asn-Trp-Phe-NH2 and the following structural formula. The drug product, FUZEON (enfuvirtide) for Injection, is a white to off-white, sterile, lyophilized powder. Each single-dose vial contains 108 mg of enfuvirtide for the delivery of 90 mg. Prior to subcutaneous administration, the contents of the vial are reconstituted with 1 mL of Sterile Water for Injection to provide the delivery of 1 mL of the solution. Each 1 mL of the reconstituted solution contains approximately 90 mg of enfuvirtide with approximate amounts of the following excipients: 22.55 mg of mannitol, 2.39 mg of sodium carbonate (anhydrous), and sodium hydroxide and hydrochloric acid for pH adjustment as needed. The reconstituted solution has an approximate pH of 9.0.</Description>
</NDC>
<NDC>
<NDCCode>0295-1110-21</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0295-1110-21) > 142 g in 1 TUBE</PackageDescription>
<NDC11Code>00295-1110-21</NDC11Code>
<ProductNDC>0295-1110</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunburnt Plus Pain Relief</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Denison Pharmaceuticals, LLC.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10572-101-01</NDCCode>
<PackageDescription>4 L in 1 JUG (10572-101-01) </PackageDescription>
<NDC11Code>10572-0101-01</NDC11Code>
<ProductNDC>10572-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Peg-3350 And Electrolytes</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<EndMarketingDate>20240229</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019011</ApplicationNumber>
<LabelerName>Affordable Pharmaceuticals, LLC</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS</SubstanceName>
<StrengthNumber>236; 2.97; 6.74; 5.86; 22.74</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090701</StartMarketingDatePackage>
<EndMarketingDatePackage>20240229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.</IndicationAndUsage>
<Description>PEG-3350 and Electrolytes for Oral Solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na 2SO 4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO 3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na + Cl -. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>10695-142-10</NDCCode>
<PackageDescription>1 kg in 1 CONTAINER (10695-142-10) </PackageDescription>
<NDC11Code>10695-0142-10</NDC11Code>
<ProductNDC>10695-142</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Maropitant Citrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20221209</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Willow Birch Pharma, Inc.</LabelerName>
<SubstanceName>MAROPITANT CITRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>09-DEC-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>17156-023-05</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (17156-023-05) * 5 VIAL in 1 TRAY / 1 mL in 1 VIAL * 5 VIAL in 1 TRAY / 4.5 mL in 1 VIAL * 5 VIAL in 1 TRAY (17156-022-05) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>17156-0023-05</NDC11Code>
<ProductNDC>17156-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ceretec</ProprietaryName>
<NonProprietaryName>Exametazime</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19881230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019829</ApplicationNumber>
<LabelerName>Medi-Physics Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-02-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Technetium Tc99m exametazime scintigraphy (with or without methylene blue stabilization) may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. Tc99m exametazime without methylene blue stabilization is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.</IndicationAndUsage>
<Description>The Ceretec kit is supplied as five packs of three vials for use in the preparation of a technetium Tc99m exametazime intravenous injection as a diagnostic radiopharmaceutical for use as an adjunct in the detection of altered regional cerebral perfusion and for the radiolabeling of autologous leukocytes. Each vial of Ceretec contains a pre-dispensed sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime [(RR,SS)-4.8-diaza-3,6,6,9-tetramethylundecane-2, 10-dione bisoxime], 7.6 µg stannous chloride dihydrate (minimum stannous tin 0.6 µg; maximum total stannous and stannic tin 4.0 µg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative. In addition, each package contains five 1 mL vials of Methylene Blue Injection USP 1% containing 10 mg methylene blue USP in Water for Injection q.s. pH adjusted with sodium hydroxide and/or hydrochloric acid, when necessary. Methylene Blue Injection USP is a sterile, non-pyrogenic solution of phenothiazin-5-ium,3,7-bis (dimethylamino)-chloride, trihydrate. Each package also contains five 4.5 mL vials of 0.003 M Monobasic Sodium Phosphate USP and Dibasic Sodium Phosphate USP in 0.9% Sodium Chloride Injection USP. The solution is sterile and non-pyrogenic. Each mL contains 0.276 mg monobasic sodium phosphate monohydrate (equivalent to 0.312 mg monobasic sodium phosphate dihydrate), 0.142 mg dibasic sodium phosphate anhydrous (equivalent to 0.178 mg dibasic sodium phosphate dihydrate) and 9 mg sodium chloride in Water for Injection q.s. The total calculated osmolarity of the 0.003 M Monobasic Sodium Phosphate USP and Dibasic Sodium Phosphate USP in 0.9% Sodium Chloride Injection USP is 317 mOsmol/L. Each mL provides 0.285 mg (3mM) of phosphate, 0.157 mEq of sodium and 0.154 mEq of chloride. When used according to the preparation instructions (see DOSAGE AND ADMINISTRATION), Methylene Blue Sodium Phosphates/Sodium Chloride mixture acts as a stabilizer. Prior to publication of the USAN, exametazime was formerly known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications. The structural formula of exametazime is. When sterile pyrogen-free sodium pertechnetate Tc99m in isotonic saline is added to the vial of Ceretec, a Tc99m complex of exametazime is formed. Administration is by intravenous injection for diagnostic use.</Description>
</NDC>
<NDC>
<NDCCode>22607-142-20</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (22607-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>22607-0142-20</NDC11Code>
<ProductNDC>22607-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<NonProprietaryName>Ampicillin And Sulbactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<StartMarketingDate>20091222</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Mitim S.r.L.</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>1; .5</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-DEC-09</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>24338-236-01</NDCCode>
<PackageDescription>4 L in 1 BOTTLE, PLASTIC (24338-236-01) </PackageDescription>
<NDC11Code>24338-0236-01</NDC11Code>
<ProductNDC>24338-236</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Golytely</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260417</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019011</ApplicationNumber>
<LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>236; 22.74; 6.74; 5.86; 2.97</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.</IndicationAndUsage>
<Description>GoLYTELY is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>25021-142-20</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>25021-0142-20</NDC11Code>
<ProductNDC>25021-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin And Sulbactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20100630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201406</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>1; .5</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin and Sulbactam for Injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,2 Klebsiella spp.2 (including K. pneumoniae2), Proteus mirabilis,2 Bacteroides fragilis,2 Enterobacter spp.,2 and Acinetobacter calcoaceticus.2. NOTE: For information on use in pediatric patients (see PRECAUTIONS–Pediatric Use and CLINICAL STUDIES sections). Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae2), Bacteroides spp. (including B. fragilis), and Enterobacter spp.2. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,2 and Bacteroides spp.2 (including B. fragilis2). _________. 2Efficacy for this organism in this organ system was studied in fewer than 10 infections. While Ampicillin and Sulbactam for Injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection and other antibacterial drugs, Ampicillin and Sulbactam for Injection should be used only to treat 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.</IndicationAndUsage>
<Description>Ampicillin and Sulbactam for Injection, USP is a sterile antibacterial fixed-combination drug product consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is:. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is:. Ampicillin and Sulbactam for Injection, USP is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Each 1.5 g vial contains ampicillin 1 g and sulbactam 0.5 g (equivalent to 1.063 g ampicillin sodium and 0.547 g sulbactam sodium). Each 1.5 g vial contains approximately 115 mg of sodium. Each 3 g vial contains ampicillin 2 g and sulbactam 1 g (equivalent to 2.125 g ampicillin sodium and 1.094 g sulbactam sodium). Each 3 g vial contains approximately 230 mg of sodium.</Description>
</NDC>
<NDC>
<NDCCode>33342-546-53</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (33342-546-53) / 177 mL in 1 BOTTLE (33342-546-23) </PackageDescription>
<NDC11Code>33342-0546-53</NDC11Code>
<ProductNDC>33342-546</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral</ProprietaryName>
<NonProprietaryName>Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219429</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE</SubstanceName>
<StrengthNumber>17.5; 3.13; 1.6</StrengthNumber>
<StrengthUnit>g/177mL; g/177mL; g/177mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult Patient. "Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREPBOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.".</IndicationAndUsage>
<Description>Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: citric acid monohydrate USP, malic acid USP, purified water, raspberry flavour, sodium benzoate USP, sucralose USP. Sodium Sulfate Anhydrous USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Potassium Sulfate, FCC The chemical name is K2SO4. The average Molecular Weight is 174.26. The structural formula is. Magnesium Sulfate Heptahydrate USP The chemical name is MgSO4. The average Molecular Weight: 120.37. The structural formula is. Each Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution also contains a polypropylene mixing container. "Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREPBOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.".</Description>
</NDC>
<NDC>
<NDCCode>40032-090-19</NDCCode>
<PackageDescription>274.31 g in 1 BOTTLE (40032-090-19) </PackageDescription>
<NDC11Code>40032-0090-19</NDC11Code>
<ProductNDC>40032-090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol-3350 And Electrolytes</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol-3350 And Electrolytes</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090231</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>236; 22.74; 6.74; 5.86; 2.97</StrengthNumber>
<StrengthUnit>g/274.31g; g/274.31g; g/274.31g; g/274.31g; g/274.31g</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PEG-3350 and electrolytes for oral solution, USP is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults (1).</IndicationAndUsage>
<Description>PEG-3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white to off-white powder. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>43386-090-19</NDCCode>
<PackageDescription>274.31 g in 1 BOTTLE (43386-090-19) </PackageDescription>
<NDC11Code>43386-0090-19</NDC11Code>
<ProductNDC>43386-090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gavilyte G</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Polyethylene Glycol-3350 And Electrolytes</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090231</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>236; 22.74; 6.74; 5.86; 2.97</StrengthNumber>
<StrengthUnit>g/274.31g; g/274.31g; g/274.31g; g/274.31g; g/274.31g</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GaviLyte-G is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (1).</IndicationAndUsage>
<Description>Gavilyte-G is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white to off-white powder. Polyethylene Glycol 3350, NF. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>43386-090-91</NDCCode>
<PackageDescription>274.31 g in 1 BOTTLE (43386-090-91)</PackageDescription>
<NDC11Code>43386-0090-91</NDC11Code>
<ProductNDC>43386-090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gavilyte G</ProprietaryName>
<ProprietaryNameSuffix>Tm</ProprietaryNameSuffix>
<NonProprietaryName>Polyethylene Glycol-3350 And Electrolytes</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090231</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>236; 22.74; 6.74; 5.86; 2.97</StrengthNumber>
<StrengthUnit>g/274.31g; g/274.31g; g/274.31g; g/274.31g; g/274.31g</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>GaviLyte-G is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults (1).</IndicationAndUsage>
<Description>For oral solution: Each 4 liter (4L) GaviLyte-G jug contains a white powder for reconstitution. GaviLyte-G is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Each 4 liter jug contains: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, NF. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>50090-6521-0</NDCCode>
<PackageDescription>4 L in 1 JUG (50090-6521-0) </PackageDescription>
<NDC11Code>50090-6521-00</NDC11Code>
<ProductNDC>50090-6521</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Peg-3350 And Electrolytes</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019011</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>236; 22.74; 6.74; 5.86; 2.97</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.</IndicationAndUsage>
<Description>PEG-3350 and Electrolytes for Oral Solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na 2SO 4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO 3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na + Cl -. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>50090-8020-0</NDCCode>
<PackageDescription>4 L in 1 JUG (50090-8020-0) </PackageDescription>
<NDC11Code>50090-8020-00</NDC11Code>
<ProductNDC>50090-8020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Peg</ProprietaryName>
<ProprietaryNameSuffix>3350 And Electrolytes</ProprietaryNameSuffix>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019011</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>236; 22.74; 6.74; 5.86; 2.97</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.</IndicationAndUsage>
<Description>PEG-3350 and Electrolytes for Oral Solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na+ Cl-. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>52268-101-01</NDCCode>
<PackageDescription>4 L in 1 BOTTLE, PLASTIC (52268-101-01) </PackageDescription>
<NDC11Code>52268-0101-01</NDC11Code>
<ProductNDC>52268-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Golytely</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840713</StartMarketingDate>
<EndMarketingDate>20221031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019011</ApplicationNumber>
<LabelerName>Braintree Laboratories, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS</SubstanceName>
<StrengthNumber>236; 2.97; 6.74; 5.86; 22.74</StrengthNumber>
<StrengthUnit>g/4L; g/4L; g/4L; g/4L; g/4L</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19840713</StartMarketingDatePackage>
<EndMarketingDatePackage>20221031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.</IndicationAndUsage>
<Description>GoLYTELY is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na 2SO 4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO 3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na + Cl -. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
</NDCList>