{
"NDC": [
{
"NDCCode": "70069-819-10",
"PackageDescription": "10 VIAL in 1 CARTON (70069-819-10) / 1 mL in 1 VIAL",
"NDC11Code": "70069-0819-10",
"ProductNDC": "70069-819",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ephedrine Sulfate",
"NonProprietaryName": "Ephedrine Sulfate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216146",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "EPHEDRINE SULFATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241107",
"SamplePackage": "N",
"IndicationAndUsage": "Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.",
"Description": "Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine Sulfate Injection, USP is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. The chemical name of ephedrine sulfate is benzenemethanol, α-[1-(methylamino)ethyl]-, [R-(R*,S*)]-, sulfate (2:1) (salt), and the molecular weight is 428.54 g/mol. Its structural formula is depicted below. Ephedrine sulfate is freely soluble in water, sparingly soluble in alcohol. Each mL contains ephedrine sulfate 50 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0."
},
{
"NDCCode": "16714-819-01",
"PackageDescription": "10 CAPSULE in 1 CARTON (16714-819-01) ",
"NDC11Code": "16714-0819-01",
"ProductNDC": "16714-819",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseltamivir Phosphate",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209438",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180903",
"SamplePackage": "N",
"IndicationAndUsage": "Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).",
"Description": "Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:."
},
{
"NDCCode": "31722-819-31",
"PackageDescription": "10 TABLET in 1 BLISTER PACK (31722-819-31) ",
"NDC11Code": "31722-0819-31",
"ProductNDC": "31722-819",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150428",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder .",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C 23H 27C l2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "49348-819-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (49348-819-10) > 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "49348-0819-10",
"ProductNDC": "49348-819",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunmark All Day Relief",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074661",
"LabelerName": "McKesson",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "51407-819-10",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-819-10) ",
"NDC11Code": "51407-0819-10",
"ProductNDC": "51407-819",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20140611",
"EndMarketingDate": "20271130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203088",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230712",
"EndMarketingDatePackage": "20271130",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules is indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C 18H 19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide."
},
{
"NDCCode": "65162-819-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (65162-819-10) ",
"NDC11Code": "65162-0819-10",
"ProductNDC": "65162-819",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208833",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180625",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated for.",
"Description": "Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib, USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib, USP is a white or almost white crystalline powder. Celecoxib oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib USP, together with inactive ingredients including: crospovidone, magnesium stearate, povidone, sodium lauryl sulfate and talc. The imprinting ink for all strengths includes: black iron oxide, potassium hydroxide, propylene glycol and shellac. The 50 mg capsule shell ingredients includes: FD&C blue #1, FD&C yellow #6, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The body imprinting ingredients includes: FD&C red #40, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. The 100 mg capsule shell ingredients includes: FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The body imprinting ingredients includes: FD&C blue #2, propylene glycol and shellac. The 200 mg capsule shell ingredients includes: iron oxide yellow, gelatin, sodium lauryl sulfate and titanium dioxide. The body imprinting ingredients includes: iron oxide yellow, propylene glycol and shellac. The 400 mg capsule shell ingredients includes: D&C yellow #10, FD&C blue #1, gelatin, sodium lauryl sulfate and titanium dioxide. The body imprinting ingredients includes: FD&C blue #1, FD&C yellow #5, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide."
},
{
"NDCCode": "65862-819-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (65862-819-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "65862-0819-03",
"ProductNDC": "65862-819",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090647",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180126",
"SamplePackage": "N",
"IndicationAndUsage": "Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: 1 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. (1.1), 2 for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 10 kg. (1.2).",
"Description": "Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) which is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase.The chemical name of TDF is 9-[(R)-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white, crystalline powder with a solubility of 13.4 mg/mL in distilled water at 25°C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25°C. Tenofovir disoproxil fumarate is available as tablets. Tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 150 mg, 200 mg, 250 mg, and 300 mg of TDF (equivalent to 123 mg, 163 mg, 204 mg, and 245 mg of tenofovir disoproxil, respectively). All strengths of tenofovir disoproxil fumarate tablets contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize) (gluten free). The 300 mg strength tablets are coated with Opadry II White 32K18425, which contains hypromellose 15cP, lactose monohydrate, titanium dioxide, and triacetin. The 150 mg, 200 mg, and 250 mg strength tablets are coated with Aquarius BT18242 Cool Vanilla, which contains hypromellose 2910, lactose monohydrate, titanium dioxide and triacetin. In this insert, all dosages are expressed in terms of TDF except where otherwise noted."
},
{
"NDCCode": "70412-819-10",
"PackageDescription": "1 KIT in 1 KIT (70412-819-10) * 4.5 g in 1 TUBE (70412-316-15) * 2 g in 1 TUBE (70412-211-00) ",
"NDC11Code": "70412-0819-10",
"ProductNDC": "70412-819",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Spf 15 Lip And Spf 30 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octocrylene, Octisalate",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Zhejiang Ayan Biotech Co.,Ltd.",
"Status": "Active",
"LastUpdate": "2023-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N"
},
{
"NDCCode": "85592-819-30",
"PackageDescription": "30 POUCH in 1 CARTON (85592-819-30) / 10 g in 1 POUCH (85592-819-01) ",
"NDC11Code": "85592-0819-30",
"ProductNDC": "85592-819",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"ProprietaryNameSuffix": "Crystalline",
"NonProprietaryName": "Lactulose",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074712",
"LabelerName": "Cumberland Assured Products Inc.",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/10g",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "LACTULOSE For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.",
"Description": "LACTULOSE is a synthetic disaccharide in the form of crystals for reconstitution prior to use for oral administration Each 10 g of lactulose contains less than 0.3 g galactose and lactose as a total sum. The pH range is 3.0 to 7.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-Galactopyranosyl-D-fructofuranose. It has the following structural formula:. The molecular formula is C12H22O11. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "70069-005-10",
"PackageDescription": "25 VIAL in 1 CARTON (70069-005-10) / 1 mL in 1 VIAL (70069-005-01) ",
"NDC11Code": "70069-0005-10",
"ProductNDC": "70069-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyanocobalamin",
"NonProprietaryName": "Cyanocobalamin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20151211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206503",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "CYANOCOBALAMIN",
"StrengthNumber": "1000",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Vitamin B 12 [CS], Vitamin B12 [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151211",
"SamplePackage": "N",
"IndicationAndUsage": "Cyanocobalamin is indicated for Vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions. Addisonian (pernicious) anemia. Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy. Fish tapeworm infestation. Malignancy of pancreas or bowel. Folic acid deficiency. It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of Vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin injection is also suitable for the Vitamin B12 absorption test (Schilling test).",
"Description": "Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous use. Each mL contains 1,000 mcg cyanocobalamin; sodium chloride 0.9%; benzyl alcohol 1.5%; Water for Injection q.s.; Hydrochloric acid and/or sodium hydroxide for pH adjustment if necessary (4.5-7.0). Cyanocobalamin appears as dark, red crystals or as an amorphous or crystalline, red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The Vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide. The cobalt content is 4.34%. The structural formula is represented below."
},
{
"NDCCode": "70069-008-10",
"PackageDescription": "10 CARTON in 1 CARTON (70069-008-10) / 1 BOTTLE in 1 CARTON (70069-008-01) / 5 mL in 1 BOTTLE",
"NDC11Code": "70069-0008-10",
"ProductNDC": "70069-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinastine Hydrochloride",
"NonProprietaryName": "Epinastine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20160914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090951",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "EPINASTINE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic Agonists [MoA], Adrenergic Receptor Agonist [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160914",
"SamplePackage": "N",
"IndicationAndUsage": "Epinastine HCl Ophthalmic Solution is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.",
"Description": "Epinastine HCl Ophthalmic Solution 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes. Epinastine HCl is represented by the following structural formula. C16H15N3HCl Mol. Wt. 285.78. Chemical Name: 3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo [1,5-a]azepine hydrochloride. Each mL contains: Active: epinastine HCl 0.05% (0.5 mg/mL) equivalent to epinastine 0.044% (0.44 mg/mL); Preservative: benzalkonium chloride 0.01%; Inactives: edetate disodium; water for injection; sodium chloride; sodium phosphate, monobasic; and sodium hydroxide and/or hydrochloric acid (to adjust pH). Epinastine HCl has a pH of approximately 7 and an osmolality range of 250 to 310 mOsm/kg."
},
{
"NDCCode": "70069-014-10",
"PackageDescription": "10 VIAL in 1 CARTON (70069-014-10) > 20 mL in 1 VIAL (70069-014-01) ",
"NDC11Code": "70069-0014-10",
"ProductNDC": "70069-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211705",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220129",
"SamplePackage": "N",
"IndicationAndUsage": "In Anesthesia. Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug‑induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. In Peptic Ulcer. For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.",
"Description": "Glycopyrrolate Injection is a synthetic anticholinergic agent. Each 1 mL contains. Glycopyrrolate, USP 0.2 mg. Water for Injection, USP q.s. Benzyl Alcohol, NF 0.9% (preservative). pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name:. 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0 – 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P = -1.52) at ambient room temperature (24°C)."
},
{
"NDCCode": "70069-025-10",
"PackageDescription": "10 VIAL in 1 CARTON (70069-025-10) / 10 mL in 1 VIAL",
"NDC11Code": "70069-0025-10",
"ProductNDC": "70069-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone Sodium Phosphate",
"NonProprietaryName": "Dexamethasone Sodium Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211036",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190611",
"SamplePackage": "N",
"IndicationAndUsage": "A. Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows. 1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. 3. Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic diseases. Pemphigus. Severe erythema multiforme (Stevens-Johnson Syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis. Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides. 5. Allergic states. Control of severe or incapacitating allergic conditions intractable to adequate. trials of conventional treatment in:. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6. Ophthalmic diseases. Severe acute and chronic allergic and inflammatory processes involving. the eye, such as:. Herpes zoster ophthalmicus. Iritis, iridocyclitis. Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis. Allergic corneal marginal ulcers. Keratitis. 7. Gastrointestinal diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8. Respiratory diseases. Symptomatic Sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate. anti-tuberculosis chemotherapy. Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9. Hematologic disorders. Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated). Secondary thrombocytopenia in adults. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10. Neoplastic diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemic of childhood. 11. Edematous states. To induce diuresis or remission of proteinuria in the nephrotic syndrome. without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Nervous system. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently. with appropriate anti-tuberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement. Diagnostic testing of adrenocortical hyperfunction. Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and. management.",
"Description": "Dexamethasone sodium phosphate injection, USP is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, C22H28FNa2O8P, has a molecular weight of 516.41 and chemically is Pregn-4-ene-3, 20-dione, 9-fluoro-11, 17-dihydroxy-16-methyl-21 (phosphonooxy)-, disodium salt, (11β, 16α). It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5. It has the following structural formula. Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preserved) 10 mg/mL contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5."
},
{
"NDCCode": "70069-051-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (70069-051-01) / 10 mL in 1 BOTTLE",
"NDC11Code": "70069-0051-01",
"ProductNDC": "70069-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
"NonProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20190625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207523",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
"StrengthNumber": "20; 5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190625",
"SamplePackage": "N",
"IndicationAndUsage": "Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].",
"Description": "Dorzolamide hydrochloride and timolol maleate ophthalmic solution USP is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride USP is described chemically as: (4S-trans)-4- (ethylamino)- 5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride USP is optically active. The specific rotation is:. [α] 25°C (C=1, water) = ~ −17°. 405 nm. Its empirical formula is C10H16N2O4S3HCl and its structural formula is. Dorzolamide hydrochloride USP has a molecular weight of 360.91. It is a white to off -white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Timolol maleate USP is described chemically as: (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate USP is:. [α] 25°C in 1N HCl (C = 5) = −12.2°(-11.7° to -12.5°). 405 nm. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate USP has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate USP is stable at room temperature. Dorzolamide hydrochloride and timolol maleate ophthalmic solution USP is supplied as a sterile, clear, colorless to nearly colorless, isotonic, buffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242 to 323 mOsM. Each mL of dorzolamide hydrochloride and timolol maleate ophthalmic solution USP contains 20 mg dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride USP) and 5 mg timolol (equivalent to 6.83 mg timolol maleate USP). Inactive ingredients are sodium citrate dihydrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection. Benzalkonium chloride 0.0075% is added as a preservative."
},
{
"NDCCode": "70069-051-12",
"PackageDescription": "12 CARTON in 1 BOX (70069-051-12) / 1 BOTTLE in 1 CARTON (70069-051-01) / 10 mL in 1 BOTTLE",
"NDC11Code": "70069-0051-12",
"ProductNDC": "70069-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
"NonProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20190625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207523",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
"StrengthNumber": "20; 5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190625",
"SamplePackage": "N",
"IndicationAndUsage": "Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].",
"Description": "Dorzolamide hydrochloride and timolol maleate ophthalmic solution USP is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride USP is described chemically as: (4S-trans)-4- (ethylamino)- 5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride USP is optically active. The specific rotation is:. [α] 25°C (C=1, water) = ~ −17°. 405 nm. Its empirical formula is C10H16N2O4S3HCl and its structural formula is. Dorzolamide hydrochloride USP has a molecular weight of 360.91. It is a white to o -white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Timolol maleate USP is described chemically as: (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate USP is:. [α] 25°C in 1N HCl (C = 5) = −12.2°(-11.7° to -12.5°). 405 nm. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate USP has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate USP is stable at room temperature. Dorzolamide hydrochloride and timolol maleate ophthalmic solution USP is supplied as a sterile, clear, colorless to nearly colorless, isotonic, bu ffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242 to 323 mOsM. Each mL of dorzolamide hydrochloride and timolol maleate ophthalmic solution USP contains 20 mg dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride USP) and 5 mg timolol (equivalent to 6.83 mg timolol maleate USP). Inactive ingredients are sodium citrate dihydrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection. Benzalkonium chloride 0.0075% is added as a preservative."
},
{
"NDCCode": "70069-061-10",
"PackageDescription": "10 VIAL in 1 CARTON (70069-061-10) / 10 mL in 1 VIAL (70069-061-01) ",
"NDC11Code": "70069-0061-10",
"ProductNDC": "70069-061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
"StartMarketingDate": "20180615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207636",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220302",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "70069-061-25",
"PackageDescription": "25 VIAL in 1 CARTON (70069-061-25) / 10 mL in 1 VIAL (70069-061-01) ",
"NDC11Code": "70069-0061-25",
"ProductNDC": "70069-061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
"StartMarketingDate": "20180615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207636",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180615",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "70069-062-10",
"PackageDescription": "10 VIAL in 1 CARTON (70069-062-10) / 20 mL in 1 VIAL (70069-062-01) ",
"NDC11Code": "70069-0062-10",
"ProductNDC": "70069-062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
"StartMarketingDate": "20180615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207636",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220302",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "70069-064-10",
"PackageDescription": "10 VIAL in 1 CARTON (70069-064-10) / 30 mL in 1 VIAL",
"NDC11Code": "70069-0064-10",
"ProductNDC": "70069-064",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
"StartMarketingDate": "20180615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207636",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211220",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "70069-066-10",
"PackageDescription": "10 VIAL in 1 CARTON (70069-066-10) / 10 mL in 1 VIAL (70069-066-01) ",
"NDC11Code": "70069-0066-10",
"ProductNDC": "70069-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "EPIDURAL",
"StartMarketingDate": "20180615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207636",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220302",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "70069-066-25",
"PackageDescription": "25 VIAL in 1 VIAL (70069-066-25) / 10 mL in 1 VIAL (70069-066-01) ",
"NDC11Code": "70069-0066-25",
"ProductNDC": "70069-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "EPIDURAL",
"StartMarketingDate": "20180615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207636",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180615",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "70069-067-10",
"PackageDescription": "10 VIAL in 1 CARTON (70069-067-10) / 20 mL in 1 VIAL (70069-067-01) ",
"NDC11Code": "70069-0067-10",
"ProductNDC": "70069-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "EPIDURAL",
"StartMarketingDate": "20180615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207636",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220302",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "70069-071-10",
"PackageDescription": "10 VIAL in 1 CARTON (70069-071-10) / 1 mL in 1 VIAL (70069-071-01) ",
"NDC11Code": "70069-0071-10",
"ProductNDC": "70069-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20170808",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207633",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170808",
"SamplePackage": "N",
"IndicationAndUsage": "Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY; Adjunctive Use in Septic Shock).",
"Description": "Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sodium chloride to adjust tonicity in water for injection. May contain hydrochloric acid for pH adjustment; pH 4.0 (3.0 to 6.5). The single-dose solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required, the unused portion should be discarded. Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. Naloxone, an opioid antagonist, is a synthetic congener of oxymorphone. It differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone Hydrochloride, USP is chemically designated 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride (C19H21NO4 HCl), a white to slightly off-white powder soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and chloroform. It has a molecular weight of 363.84. It has the following structural formula."
},
{
"NDCCode": "70069-072-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (70069-072-01) > 10 mL in 1 VIAL, GLASS",
"NDC11Code": "70069-0072-01",
"ProductNDC": "70069-072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20170803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207634",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Antagonist [EPC],Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-08-29"
},
{
"NDCCode": "70069-072-10",
"PackageDescription": "10 CARTON in 1 BOX (70069-072-10) / 1 VIAL, GLASS in 1 CARTON (70069-072-01) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "70069-0072-10",
"ProductNDC": "70069-072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20170726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207634",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170726",
"SamplePackage": "N",
"IndicationAndUsage": "Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY; Adjunctive Use in Septic Shock).",
"Description": "Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sodium chloride to adjust tonicity in water for injection. May contain hydrochloric acid for pH adjustment; pH 4.0 (3.0 to 6.5). The multiple-dose solution contains, in addition, 1.8 mg/mL methylparaben and 0.2 mg/mL propylparaben added as preservatives. Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. Naloxone, an opioid antagonist, is a synthetic congener of oxymorphone. It differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone Hydrochloride, USP is chemically designated 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride (C19H21NO4 HCl), a white to slightly off-white powder soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and chloroform. It has a molecular weight of 363.84. It has the following structural formula."
},
{
"NDCCode": "70069-101-05",
"PackageDescription": "5 VIAL in 1 CARTON (70069-101-05) / 10 mL in 1 VIAL",
"NDC11Code": "70069-0101-05",
"ProductNDC": "70069-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20170731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207522",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170731",
"SamplePackage": "N",
"IndicationAndUsage": "The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol injection, USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q. s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula of C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol injection, USP has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE."
},
{
"NDCCode": "70069-101-10",
"PackageDescription": "10 VIAL in 1 CARTON (70069-101-10) / 10 mL in 1 VIAL",
"NDC11Code": "70069-0101-10",
"ProductNDC": "70069-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20170731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207522",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170731",
"SamplePackage": "N",
"IndicationAndUsage": "The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol injection, USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q. s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula of C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol injection, USP has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE."
},
{
"NDCCode": "70069-101-25",
"PackageDescription": "25 VIAL in 1 CARTON (70069-101-25) / 10 mL in 1 VIAL",
"NDC11Code": "70069-0101-25",
"ProductNDC": "70069-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20170731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207522",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170731",
"SamplePackage": "N",
"IndicationAndUsage": "The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol injection, USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q. s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula of C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol injection, USP has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE."
},
{
"NDCCode": "70069-141-10",
"PackageDescription": "10 VIAL in 1 CARTON (70069-141-10) / 5 mL in 1 VIAL",
"NDC11Code": "70069-0141-10",
"ProductNDC": "70069-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cisatracurium Besylate",
"NonProprietaryName": "Cisatracurium Besylate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206791",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "CISATRACURIUM BESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190204",
"SamplePackage": "N",
"IndicationAndUsage": "Cisatracurium besylate injection, USP is indicated: 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age, 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU, 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older.",
"Description": "Cisatracurium besylate injection, USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate injection contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1- propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.50. The structural formula of cisatracurium besylate is:. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/ distilled water system at 25°C. Cisatracurium besylate injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection. Each mL in the multiple-dose vials contains 2 mg of cisatracurium (equivalent to 2.68 mg of cisatracurium besylate), benzenesulfonic acid as pH adjuster, and also contains 9 mg of benzyl alcohol as preservative, in water for injection. The pH of cisatracurium besylate injection is between 3.0 and 3.8."
},
{
"NDCCode": "70069-151-10",
"PackageDescription": "10 VIAL in 1 CARTON (70069-151-10) / 20 mL in 1 VIAL",
"NDC11Code": "70069-0151-10",
"ProductNDC": "70069-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cisatracurium Besylate",
"NonProprietaryName": "Cisatracurium Besylate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206791",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "CISATRACURIUM BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190204",
"SamplePackage": "N",
"IndicationAndUsage": "Cisatracurium besylate injection, USP is indicated: 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age, 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU, 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older.",
"Description": "Cisatracurium besylate injection, USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate injection contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1- propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.50. The structural formula of cisatracurium besylate is:. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/ distilled water system at 25°C. Cisatracurium besylate injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection. Each mL in the multiple-dose vials contains 2 mg of cisatracurium (equivalent to 2.68 mg of cisatracurium besylate), benzenesulfonic acid as pH adjuster, and also contains 9 mg of benzyl alcohol as preservative, in water for injection. The pH of cisatracurium besylate injection is between 3.0 and 3.8."
}
]
}
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<NDCList>
<NDC>
<NDCCode>70069-819-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70069-819-10) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>70069-0819-10</NDC11Code>
<ProductNDC>70069-819</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ephedrine Sulfate</ProprietaryName>
<NonProprietaryName>Ephedrine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216146</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>EPHEDRINE SULFATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.</IndicationAndUsage>
<Description>Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine Sulfate Injection, USP is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. The chemical name of ephedrine sulfate is benzenemethanol, α-[1-(methylamino)ethyl]-, [R-(R*,S*)]-, sulfate (2:1) (salt), and the molecular weight is 428.54 g/mol. Its structural formula is depicted below. Ephedrine sulfate is freely soluble in water, sparingly soluble in alcohol. Each mL contains ephedrine sulfate 50 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>16714-819-01</NDCCode>
<PackageDescription>10 CAPSULE in 1 CARTON (16714-819-01) </PackageDescription>
<NDC11Code>16714-0819-01</NDC11Code>
<ProductNDC>16714-819</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209438</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).</IndicationAndUsage>
<Description>Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C16H28N2O4.H3PO4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>31722-819-31</NDCCode>
<PackageDescription>10 TABLET in 1 BLISTER PACK (31722-819-31) </PackageDescription>
<NDC11Code>31722-0819-31</NDC11Code>
<ProductNDC>31722-819</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder .</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C 23H 27C l2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>49348-819-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49348-819-10) > 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>49348-0819-10</NDC11Code>
<ProductNDC>49348-819</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunmark All Day Relief</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074661</ApplicationNumber>
<LabelerName>McKesson</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51407-819-10</NDCCode>
<PackageDescription>1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-819-10) </PackageDescription>
<NDC11Code>51407-0819-10</NDC11Code>
<ProductNDC>51407-819</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140611</StartMarketingDate>
<EndMarketingDate>20271130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203088</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230712</StartMarketingDatePackage>
<EndMarketingDatePackage>20271130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules is indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C 18H 19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, 40 or 60 mg of duloxetine (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>65162-819-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (65162-819-10) </PackageDescription>
<NDC11Code>65162-0819-10</NDC11Code>
<ProductNDC>65162-819</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208833</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated for.</IndicationAndUsage>
<Description>Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib, USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib, USP is a white or almost white crystalline powder. Celecoxib oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib USP, together with inactive ingredients including: crospovidone, magnesium stearate, povidone, sodium lauryl sulfate and talc. The imprinting ink for all strengths includes: black iron oxide, potassium hydroxide, propylene glycol and shellac. The 50 mg capsule shell ingredients includes: FD&C blue #1, FD&C yellow #6, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The body imprinting ingredients includes: FD&C red #40, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. The 100 mg capsule shell ingredients includes: FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The body imprinting ingredients includes: FD&C blue #2, propylene glycol and shellac. The 200 mg capsule shell ingredients includes: iron oxide yellow, gelatin, sodium lauryl sulfate and titanium dioxide. The body imprinting ingredients includes: iron oxide yellow, propylene glycol and shellac. The 400 mg capsule shell ingredients includes: D&C yellow #10, FD&C blue #1, gelatin, sodium lauryl sulfate and titanium dioxide. The body imprinting ingredients includes: FD&C blue #1, FD&C yellow #5, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65862-819-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (65862-819-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65862-0819-03</NDC11Code>
<ProductNDC>65862-819</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tenofovir Disoproxil Fumarate</ProprietaryName>
<NonProprietaryName>Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090647</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: 1 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. (1.1), 2 for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 10 kg. (1.2).</IndicationAndUsage>
<Description>Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) which is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase.The chemical name of TDF is 9-[(R)-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white, crystalline powder with a solubility of 13.4 mg/mL in distilled water at 25°C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25°C. Tenofovir disoproxil fumarate is available as tablets. Tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 150 mg, 200 mg, 250 mg, and 300 mg of TDF (equivalent to 123 mg, 163 mg, 204 mg, and 245 mg of tenofovir disoproxil, respectively). All strengths of tenofovir disoproxil fumarate tablets contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize) (gluten free). The 300 mg strength tablets are coated with Opadry II White 32K18425, which contains hypromellose 15cP, lactose monohydrate, titanium dioxide, and triacetin. The 150 mg, 200 mg, and 250 mg strength tablets are coated with Aquarius BT18242 Cool Vanilla, which contains hypromellose 2910, lactose monohydrate, titanium dioxide and triacetin. In this insert, all dosages are expressed in terms of TDF except where otherwise noted.</Description>
</NDC>
<NDC>
<NDCCode>70412-819-10</NDCCode>
<PackageDescription>1 KIT in 1 KIT (70412-819-10) * 4.5 g in 1 TUBE (70412-316-15) * 2 g in 1 TUBE (70412-211-00) </PackageDescription>
<NDC11Code>70412-0819-10</NDC11Code>
<ProductNDC>70412-819</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Spf 15 Lip And Spf 30 Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octocrylene, Octisalate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Zhejiang Ayan Biotech Co.,Ltd.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>85592-819-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (85592-819-30) / 10 g in 1 POUCH (85592-819-01) </PackageDescription>
<NDC11Code>85592-0819-30</NDC11Code>
<ProductNDC>85592-819</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<ProprietaryNameSuffix>Crystalline</ProprietaryNameSuffix>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074712</ApplicationNumber>
<LabelerName>Cumberland Assured Products Inc.</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/10g</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LACTULOSE For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
<Description>LACTULOSE is a synthetic disaccharide in the form of crystals for reconstitution prior to use for oral administration Each 10 g of lactulose contains less than 0.3 g galactose and lactose as a total sum. The pH range is 3.0 to 7.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-Galactopyranosyl-D-fructofuranose. It has the following structural formula:. The molecular formula is C12H22O11. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>70069-005-10</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (70069-005-10) / 1 mL in 1 VIAL (70069-005-01) </PackageDescription>
<NDC11Code>70069-0005-10</NDC11Code>
<ProductNDC>70069-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyanocobalamin</ProprietaryName>
<NonProprietaryName>Cyanocobalamin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20151211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206503</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyanocobalamin is indicated for Vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions. Addisonian (pernicious) anemia. Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy. Fish tapeworm infestation. Malignancy of pancreas or bowel. Folic acid deficiency. It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of Vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin injection is also suitable for the Vitamin B12 absorption test (Schilling test).</IndicationAndUsage>
<Description>Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous use. Each mL contains 1,000 mcg cyanocobalamin; sodium chloride 0.9%; benzyl alcohol 1.5%; Water for Injection q.s.; Hydrochloric acid and/or sodium hydroxide for pH adjustment if necessary (4.5-7.0). Cyanocobalamin appears as dark, red crystals or as an amorphous or crystalline, red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The Vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide. The cobalt content is 4.34%. The structural formula is represented below.</Description>
</NDC>
<NDC>
<NDCCode>70069-008-10</NDCCode>
<PackageDescription>10 CARTON in 1 CARTON (70069-008-10) / 1 BOTTLE in 1 CARTON (70069-008-01) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70069-0008-10</NDC11Code>
<ProductNDC>70069-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinastine Hydrochloride</ProprietaryName>
<NonProprietaryName>Epinastine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20160914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090951</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>EPINASTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic Agonists [MoA], Adrenergic Receptor Agonist [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Epinastine HCl Ophthalmic Solution is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.</IndicationAndUsage>
<Description>Epinastine HCl Ophthalmic Solution 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes. Epinastine HCl is represented by the following structural formula. C16H15N3HCl Mol. Wt. 285.78. Chemical Name: 3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo [1,5-a]azepine hydrochloride. Each mL contains: Active: epinastine HCl 0.05% (0.5 mg/mL) equivalent to epinastine 0.044% (0.44 mg/mL); Preservative: benzalkonium chloride 0.01%; Inactives: edetate disodium; water for injection; sodium chloride; sodium phosphate, monobasic; and sodium hydroxide and/or hydrochloric acid (to adjust pH). Epinastine HCl has a pH of approximately 7 and an osmolality range of 250 to 310 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>70069-014-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70069-014-10) > 20 mL in 1 VIAL (70069-014-01) </PackageDescription>
<NDC11Code>70069-0014-10</NDC11Code>
<ProductNDC>70069-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20220129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211705</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In Anesthesia. Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug‑induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. In Peptic Ulcer. For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.</IndicationAndUsage>
<Description>Glycopyrrolate Injection is a synthetic anticholinergic agent. Each 1 mL contains. Glycopyrrolate, USP 0.2 mg. Water for Injection, USP q.s. Benzyl Alcohol, NF 0.9% (preservative). pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name:. 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.Its structural formula is as follows. Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection is a clear, colorless, sterile liquid; pH 2.0 – 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P = -1.52) at ambient room temperature (24°C).</Description>
</NDC>
<NDC>
<NDCCode>70069-025-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70069-025-10) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>70069-0025-10</NDC11Code>
<ProductNDC>70069-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211036</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>A. Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows. 1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. 3. Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic diseases. Pemphigus. Severe erythema multiforme (Stevens-Johnson Syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis. Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides. 5. Allergic states. Control of severe or incapacitating allergic conditions intractable to adequate. trials of conventional treatment in:. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6. Ophthalmic diseases. Severe acute and chronic allergic and inflammatory processes involving. the eye, such as:. Herpes zoster ophthalmicus. Iritis, iridocyclitis. Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis. Allergic corneal marginal ulcers. Keratitis. 7. Gastrointestinal diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8. Respiratory diseases. Symptomatic Sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate. anti-tuberculosis chemotherapy. Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9. Hematologic disorders. Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated). Secondary thrombocytopenia in adults. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10. Neoplastic diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemic of childhood. 11. Edematous states. To induce diuresis or remission of proteinuria in the nephrotic syndrome. without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Nervous system. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently. with appropriate anti-tuberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement. Diagnostic testing of adrenocortical hyperfunction. Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and. management.</IndicationAndUsage>
<Description>Dexamethasone sodium phosphate injection, USP is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, C22H28FNa2O8P, has a molecular weight of 516.41 and chemically is Pregn-4-ene-3, 20-dione, 9-fluoro-11, 17-dihydroxy-16-methyl-21 (phosphonooxy)-, disodium salt, (11β, 16α). It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5. It has the following structural formula. Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preserved) 10 mg/mL contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>70069-051-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70069-051-01) / 10 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70069-0051-01</NDC11Code>
<ProductNDC>70069-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</ProprietaryName>
<NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20190625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207523</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>20; 5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dorzolamide hydrochloride and timolol maleate ophthalmic solution USP is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride USP is described chemically as: (4S-trans)-4- (ethylamino)- 5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride USP is optically active. The specific rotation is:. [α] 25°C (C=1, water) = ~ −17°. 405 nm. Its empirical formula is C10H16N2O4S3HCl and its structural formula is. Dorzolamide hydrochloride USP has a molecular weight of 360.91. It is a white to off -white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Timolol maleate USP is described chemically as: (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate USP is:. [α] 25°C in 1N HCl (C = 5) = −12.2°(-11.7° to -12.5°). 405 nm. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate USP has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate USP is stable at room temperature. Dorzolamide hydrochloride and timolol maleate ophthalmic solution USP is supplied as a sterile, clear, colorless to nearly colorless, isotonic, buffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242 to 323 mOsM. Each mL of dorzolamide hydrochloride and timolol maleate ophthalmic solution USP contains 20 mg dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride USP) and 5 mg timolol (equivalent to 6.83 mg timolol maleate USP). Inactive ingredients are sodium citrate dihydrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection. Benzalkonium chloride 0.0075% is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>70069-051-12</NDCCode>
<PackageDescription>12 CARTON in 1 BOX (70069-051-12) / 1 BOTTLE in 1 CARTON (70069-051-01) / 10 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70069-0051-12</NDC11Code>
<ProductNDC>70069-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</ProprietaryName>
<NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20190625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207523</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>20; 5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dorzolamide hydrochloride and timolol maleate ophthalmic solution USP is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride USP is described chemically as: (4S-trans)-4- (ethylamino)- 5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride USP is optically active. The specific rotation is:. [α] 25°C (C=1, water) = ~ −17°. 405 nm. Its empirical formula is C10H16N2O4S3HCl and its structural formula is. Dorzolamide hydrochloride USP has a molecular weight of 360.91. It is a white to o -white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Timolol maleate USP is described chemically as: (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate USP is:. [α] 25°C in 1N HCl (C = 5) = −12.2°(-11.7° to -12.5°). 405 nm. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate USP has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate USP is stable at room temperature. Dorzolamide hydrochloride and timolol maleate ophthalmic solution USP is supplied as a sterile, clear, colorless to nearly colorless, isotonic, bu ffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242 to 323 mOsM. Each mL of dorzolamide hydrochloride and timolol maleate ophthalmic solution USP contains 20 mg dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride USP) and 5 mg timolol (equivalent to 6.83 mg timolol maleate USP). Inactive ingredients are sodium citrate dihydrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection. Benzalkonium chloride 0.0075% is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>70069-061-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70069-061-10) / 10 mL in 1 VIAL (70069-061-01) </PackageDescription>
<NDC11Code>70069-0061-10</NDC11Code>
<ProductNDC>70069-061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20180615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207636</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>70069-061-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (70069-061-25) / 10 mL in 1 VIAL (70069-061-01) </PackageDescription>
<NDC11Code>70069-0061-25</NDC11Code>
<ProductNDC>70069-061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20180615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207636</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>70069-062-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70069-062-10) / 20 mL in 1 VIAL (70069-062-01) </PackageDescription>
<NDC11Code>70069-0062-10</NDC11Code>
<ProductNDC>70069-062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20180615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207636</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>70069-064-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70069-064-10) / 30 mL in 1 VIAL</PackageDescription>
<NDC11Code>70069-0064-10</NDC11Code>
<ProductNDC>70069-064</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20180615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207636</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>70069-066-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70069-066-10) / 10 mL in 1 VIAL (70069-066-01) </PackageDescription>
<NDC11Code>70069-0066-10</NDC11Code>
<ProductNDC>70069-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>EPIDURAL</RouteName>
<StartMarketingDate>20180615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207636</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>70069-066-25</NDCCode>
<PackageDescription>25 VIAL in 1 VIAL (70069-066-25) / 10 mL in 1 VIAL (70069-066-01) </PackageDescription>
<NDC11Code>70069-0066-25</NDC11Code>
<ProductNDC>70069-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>EPIDURAL</RouteName>
<StartMarketingDate>20180615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207636</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>70069-067-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70069-067-10) / 20 mL in 1 VIAL (70069-067-01) </PackageDescription>
<NDC11Code>70069-0067-10</NDC11Code>
<ProductNDC>70069-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>EPIDURAL</RouteName>
<StartMarketingDate>20180615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207636</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2 mg, 5 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous) and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>70069-071-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70069-071-10) / 1 mL in 1 VIAL (70069-071-01) </PackageDescription>
<NDC11Code>70069-0071-10</NDC11Code>
<ProductNDC>70069-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170808</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207633</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY; Adjunctive Use in Septic Shock).</IndicationAndUsage>
<Description>Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sodium chloride to adjust tonicity in water for injection. May contain hydrochloric acid for pH adjustment; pH 4.0 (3.0 to 6.5). The single-dose solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required, the unused portion should be discarded. Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. Naloxone, an opioid antagonist, is a synthetic congener of oxymorphone. It differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone Hydrochloride, USP is chemically designated 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride (C19H21NO4 HCl), a white to slightly off-white powder soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and chloroform. It has a molecular weight of 363.84. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>70069-072-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (70069-072-01) > 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>70069-0072-01</NDC11Code>
<ProductNDC>70069-072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207634</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC],Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>70069-072-10</NDCCode>
<PackageDescription>10 CARTON in 1 BOX (70069-072-10) / 1 VIAL, GLASS in 1 CARTON (70069-072-01) / 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>70069-0072-10</NDC11Code>
<ProductNDC>70069-072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20170726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207634</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY; Adjunctive Use in Septic Shock).</IndicationAndUsage>
<Description>Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sodium chloride to adjust tonicity in water for injection. May contain hydrochloric acid for pH adjustment; pH 4.0 (3.0 to 6.5). The multiple-dose solution contains, in addition, 1.8 mg/mL methylparaben and 0.2 mg/mL propylparaben added as preservatives. Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. Naloxone, an opioid antagonist, is a synthetic congener of oxymorphone. It differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone Hydrochloride, USP is chemically designated 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride (C19H21NO4 HCl), a white to slightly off-white powder soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and chloroform. It has a molecular weight of 363.84. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>70069-101-05</NDCCode>
<PackageDescription>5 VIAL in 1 CARTON (70069-101-05) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>70069-0101-05</NDC11Code>
<ProductNDC>70069-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20170731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207522</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol injection, USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q. s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula of C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol injection, USP has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE.</Description>
</NDC>
<NDC>
<NDCCode>70069-101-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70069-101-10) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>70069-0101-10</NDC11Code>
<ProductNDC>70069-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20170731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207522</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol injection, USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q. s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula of C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol injection, USP has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE.</Description>
</NDC>
<NDC>
<NDCCode>70069-101-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (70069-101-25) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>70069-0101-25</NDC11Code>
<ProductNDC>70069-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20170731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207522</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol injection, USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q. s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula of C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol injection, USP has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE.</Description>
</NDC>
<NDC>
<NDCCode>70069-141-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70069-141-10) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>70069-0141-10</NDC11Code>
<ProductNDC>70069-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cisatracurium Besylate</ProprietaryName>
<NonProprietaryName>Cisatracurium Besylate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206791</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>CISATRACURIUM BESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cisatracurium besylate injection, USP is indicated: 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age, 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU, 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older.</IndicationAndUsage>
<Description>Cisatracurium besylate injection, USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate injection contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1- propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.50. The structural formula of cisatracurium besylate is:. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/ distilled water system at 25°C. Cisatracurium besylate injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection. Each mL in the multiple-dose vials contains 2 mg of cisatracurium (equivalent to 2.68 mg of cisatracurium besylate), benzenesulfonic acid as pH adjuster, and also contains 9 mg of benzyl alcohol as preservative, in water for injection. The pH of cisatracurium besylate injection is between 3.0 and 3.8.</Description>
</NDC>
<NDC>
<NDCCode>70069-151-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70069-151-10) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>70069-0151-10</NDC11Code>
<ProductNDC>70069-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cisatracurium Besylate</ProprietaryName>
<NonProprietaryName>Cisatracurium Besylate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206791</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>CISATRACURIUM BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cisatracurium besylate injection, USP is indicated: 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age, 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU, 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older.</IndicationAndUsage>
<Description>Cisatracurium besylate injection, USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate injection contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1- propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.50. The structural formula of cisatracurium besylate is:. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/ distilled water system at 25°C. Cisatracurium besylate injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection. Each mL in the multiple-dose vials contains 2 mg of cisatracurium (equivalent to 2.68 mg of cisatracurium besylate), benzenesulfonic acid as pH adjuster, and also contains 9 mg of benzyl alcohol as preservative, in water for injection. The pH of cisatracurium besylate injection is between 3.0 and 3.8.</Description>
</NDC>
</NDCList>