{
"NDC": [
{
"NDCCode": "51662-1556-2",
"PackageDescription": "1 AMPULE in 1 POUCH (51662-1556-2) / 1 mL in 1 AMPULE (51662-1556-1) ",
"NDC11Code": "51662-1556-02",
"ProductNDC": "51662-1556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylergonovine Maleate",
"NonProprietaryName": "Methylergonovine Maleate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040889",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "METHYLERGONOVINE MALEATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210614",
"SamplePackage": "N",
"IndicationAndUsage": "Following delivery of the placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.",
"Description": "Methylergonovine Maleate Injection, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Injection, USP is available in sterile ampules of 1 mL, containing 0.2 mg methylergonovine maleate for intramuscular or intravenous injection. Ampules, 1 mL, clear, colorless solution. Active Ingredients: methylergonovine maleate, USP, 0.2 mg. Inactive Ingredients: maleic acid, 0.10 mg; sodium chloride, 7.0 mg; water for injection, qs to 1 mL. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9,10-didehydro-N-[l-(hydroxymethyl)propyl ]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is. C20H25N3O2∙C4H4O4 Mol. wt. - 455.51."
},
{
"NDCCode": "51662-1556-1",
"PackageDescription": "1 mL in 1 AMPULE (51662-1556-1) ",
"NDC11Code": "51662-1556-01",
"ProductNDC": "51662-1556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylergonovine Maleate",
"NonProprietaryName": "Methylergonovine Maleate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040889",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "METHYLERGONOVINE MALEATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210614",
"SamplePackage": "N",
"IndicationAndUsage": "Following delivery of the placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.",
"Description": "Methylergonovine Maleate Injection, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Injection, USP is available in sterile ampules of 1 mL, containing 0.2 mg methylergonovine maleate for intramuscular or intravenous injection. Ampules, 1 mL, clear, colorless solution. Active Ingredients: methylergonovine maleate, USP, 0.2 mg. Inactive Ingredients: maleic acid, 0.10 mg; sodium chloride, 7.0 mg; water for injection, qs to 1 mL. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9,10-didehydro-N-[l-(hydroxymethyl)propyl ]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is. C20H25N3O2∙C4H4O4 Mol. wt. - 455.51."
},
{
"NDCCode": "22840-1556-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-1556-2) ",
"NDC11Code": "22840-1556-02",
"ProductNDC": "22840-1556",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Gum Arabic",
"NonProprietaryName": "Acacia Senegal",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "ACACIA",
"StrengthNumber": ".01",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens.",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "24286-1556-2",
"PackageDescription": "1 TUBE in 1 BOX (24286-1556-2) / 71 g in 1 TUBE",
"NDC11Code": "24286-1556-02",
"ProductNDC": "24286-1556",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Earths Care Acne Treatment Mask",
"NonProprietaryName": "Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130118",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "DLC Laboratories, Inc.",
"SubstanceName": "SULFUR",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130118",
"SamplePackage": "N",
"IndicationAndUsage": "for the treatment of acne: 1 penetrates the pores and dries and clears pimples and blackheads, 2 helps to keep new pimples and black heads from forming. ."
},
{
"NDCCode": "24286-1556-3",
"PackageDescription": "2.8 g in 1 POUCH (24286-1556-3) ",
"NDC11Code": "24286-1556-03",
"ProductNDC": "24286-1556",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Earths Care Acne Treatment Mask",
"NonProprietaryName": "Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130118",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "DLC Laboratories, Inc.",
"SubstanceName": "SULFUR",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150501",
"SamplePackage": "N",
"IndicationAndUsage": "for the treatment of acne: 1 penetrates the pores and dries and clears pimples and blackheads, 2 helps to keep new pimples and black heads from forming. ."
},
{
"NDCCode": "36987-1556-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1556-2)",
"NDC11Code": "36987-1556-02",
"ProductNDC": "36987-1556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pecan Nut",
"NonProprietaryName": "Pecan Nut",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "PECAN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-1556-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-1556-2) ",
"NDC11Code": "37662-1556-02",
"ProductNDC": "37662-1556",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Manganum Sulphuricum",
"NonProprietaryName": "Manganum Sulphuricum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MANGANESE SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N"
},
{
"NDCCode": "50090-1556-2",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (50090-1556-2)",
"NDC11Code": "50090-1556-02",
"ProductNDC": "50090-1556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "67296-1556-2",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (67296-1556-2) ",
"NDC11Code": "67296-1556-02",
"ProductNDC": "67296-1556",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dok",
"NonProprietaryName": "Dok",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "70518-1556-1",
"PackageDescription": "100 POUCH in 1 BOX (70518-1556-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-1556-2) ",
"NDC11Code": "70518-1556-01",
"ProductNDC": "70518-1556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203730",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190710",
"SamplePackage": "N",
"IndicationAndUsage": "Divalproex sodium extended-release tablets are indicated for: 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1)., 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2). , 3 Prophylaxis of migraine headaches (1.3). .",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium extended-release tablets USP, 250 mg and 500 mg are for oral administration. Divalproex sodium extended-release tablets, USP contain divalproex sodium, USP in a once-a-day extended-release formulation equivalent to 250 and 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium extended-release tablets USP, 250 mg and 500 mg: ammonium hydroxide, ethyl acrylate and methyl methacrylate co-polymer dispersion, hypromellose, iron oxide, isopropyl alcohol, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, polyvinyl alcohol, propylene glycol, shellac, silicon dioxide, talc, and titanium dioxide. Meets USP Dissolution Test 13."
},
{
"NDCCode": "71335-1556-2",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (71335-1556-2) ",
"NDC11Code": "71335-1556-02",
"ProductNDC": "71335-1556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prazosin Hydrochloride",
"NonProprietaryName": "Prazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19890228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072575",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "PRAZOSIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220502",
"SamplePackage": "N"
},
{
"NDCCode": "0115-1556-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1556-01) ",
"NDC11Code": "00115-1556-01",
"ProductNDC": "0115-1556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022272",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160222",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone HCl extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in: 1 Adults; and, 2 Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent.",
"Description": "Oxycodone HCl extended-release tablets are an opioid agonist supplied in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows. C18 H21 NO4 ∙ HCl MW 351.83. The chemical name is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg tablets contain the following inactive ingredients: butylated hydroxytoluene (BHT), hypromellose, polyethylene glycol 400, polyethylene oxide, magnesium stearate, titanium dioxide. The 10 mg tablets also contain hydroxypropyl cellulose. The 15 mg tablets also contain black iron oxide, yellow iron oxide, and red iron oxide. The 20 mg tablets also contain polysorbate 80 and red iron oxide. The 30 mg tablets also contain polysorbate 80, red iron oxide, yellow iron oxide, and black iron oxide. The 40 mg tablets also contain polysorbate 80 and yellow iron oxide. The 60 mg tablets also contain polysorbate 80, red iron oxide and black iron oxide. The 80 mg tablets also contain hydroxypropyl cellulose, yellow iron oxide and FD&C Blue #2/Indigo Carmine Aluminum Lake."
},
{
"NDCCode": "0781-1556-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0781-1556-01) ",
"NDC11Code": "00781-1556-01",
"ProductNDC": "0781-1556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Dinitrate",
"NonProprietaryName": "Isosorbide Dinitrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086223",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "ISOSORBIDE DINITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880107",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is. The organic nitrates are vasodilators, active on both arteries and veins. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate is available as 5 mg, 10 mg, and 20 mg tablets for oral administration. Inactive ingredients: lactose (monohydrate), magnesium stearate, microcrystalline cellulose. The 5 mg also contains FD & C Red #40 Aluminum Lake. The 20 mg also contains D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, and FD & C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "0781-1556-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (0781-1556-05) ",
"NDC11Code": "00781-1556-05",
"ProductNDC": "0781-1556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Dinitrate",
"NonProprietaryName": "Isosorbide Dinitrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086223",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "ISOSORBIDE DINITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880107",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is. The organic nitrates are vasodilators, active on both arteries and veins. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate is available as 5 mg, 10 mg, and 20 mg tablets for oral administration. Inactive ingredients: lactose (monohydrate), magnesium stearate, microcrystalline cellulose. The 5 mg also contains FD & C Red #40 Aluminum Lake. The 20 mg also contains D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, and FD & C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "0781-1556-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0781-1556-10) ",
"NDC11Code": "00781-1556-10",
"ProductNDC": "0781-1556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Dinitrate",
"NonProprietaryName": "Isosorbide Dinitrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086223",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "ISOSORBIDE DINITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880107",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is. The organic nitrates are vasodilators, active on both arteries and veins. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate is available as 5 mg, 10 mg, and 20 mg tablets for oral administration. Inactive ingredients: lactose (monohydrate), magnesium stearate, microcrystalline cellulose. The 5 mg also contains FD & C Red #40 Aluminum Lake. The 20 mg also contains D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, and FD & C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "53002-1556-0",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (53002-1556-0) ",
"NDC11Code": "53002-1556-00",
"ProductNDC": "53002-1556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078332",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: : 1 mild to severe chronic heart failure (1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose.Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2."
},
{
"NDCCode": "53002-1556-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (53002-1556-3) ",
"NDC11Code": "53002-1556-03",
"ProductNDC": "53002-1556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078332",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: : 1 mild to severe chronic heart failure (1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose.Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2."
},
{
"NDCCode": "51662-1201-1",
"PackageDescription": "2 mL in 1 VIAL (51662-1201-1) ",
"NDC11Code": "51662-1201-01",
"ProductNDC": "51662-1201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adenosine Injection, 6mg/2ml (3mg/ml) Vial",
"NonProprietaryName": "Adenosine Injection, 6mg/2ml (3mg/ml) Vial",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078076",
"LabelerName": "HF Acquisition Co. LLC, DBA Health First",
"SubstanceName": "ADENOSINE",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180714",
"SamplePackage": "N",
"IndicationAndUsage": "Adenosine injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine administration. It is important to be sure the adenosine solution actually reaches the systemic circulation ( See Dosage and Administration). Adenosine does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine administration.",
"Description": "Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-β-D-ribofuranosyl-9-H-purine with the structural formula. Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine injection is a sterile, nonpyrogenic solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine, and 9 mg sodium chloride, in Water for Injection. The pH of the solution is between 4.5 and 7.5."
},
{
"NDCCode": "51662-1201-3",
"PackageDescription": "20 POUCH in 1 CASE (51662-1201-3) > 1 mL in 1 POUCH (51662-1201-2) ",
"NDC11Code": "51662-1201-03",
"ProductNDC": "51662-1201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adenosine Injection, 6mg/2ml (3mg/ml) Vial",
"NonProprietaryName": "Adenosine Injection, 6mg/2ml (3mg/ml) Vial",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078076",
"LabelerName": "HF Acquisition Co. LLC, DBA Health First",
"SubstanceName": "ADENOSINE",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "N"
},
{
"NDCCode": "51662-1204-3",
"PackageDescription": "25 POUCH in 1 CASE (51662-1204-3) / 1 mL in 1 POUCH (51662-1204-2) ",
"NDC11Code": "51662-1204-03",
"ProductNDC": "51662-1204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminophylline",
"NonProprietaryName": "Aminophylline",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087242",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "AMINOPHYLLINE DIHYDRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Methylxanthine [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "N",
"IndicationAndUsage": "Intravenous theophylline is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.",
"Description": "Aminophylline Injection, USP is a sterile, nonpyrogenic solution of aminophylline in water for injection. Aminophylline (dihydrate) is approximately 79% of anhydrous theophylline by weight. Aminophylline Injection is administered by slow intravenous injection or diluted and administered by intravenous infusion. The solution contains no bacteriostat or antimicrobial agent and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Aminophylline is a 2:1 complex of theophylline and ethylenediamine. Theophylline is structurally classified as a methylxanthine. Aminophylline occurs as a white or slightly yellowish granule or powder, with a slight ammoniacal odor. Aminophylline has the chemical name 1H-Purine-2, 6-dione, 3,7-dihydro-1,3-dimethyl-, compound with 1,2-ethanediamine (2:1). The structural formula of aminophylline (dihydrate) is as follows. The molecular formula of aminophylline dihydrate is C16H24N10O4 2(H2O) with a molecular weight of 456.46. Aminophylline Injection, USP contains aminophylline (calculated as the dihydrate) 25 mg/mL (equivalent to 19.7 mg/mL anhydrous theophylline) prepared with the aid of ethylenediamine. The solution may contain an excess of ethylenediamine for pH adjustment. pH is 8.8 (8.6 to 9.0). The osmolar concentration is 0.17 mOsmol/mL (calc.)."
},
{
"NDCCode": "51662-1205-3",
"PackageDescription": "25 POUCH in 1 CASE (51662-1205-3) / 1 mL in 1 POUCH (51662-1205-2) ",
"NDC11Code": "51662-1205-03",
"ProductNDC": "51662-1205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amiodarone Hydrochloride",
"NonProprietaryName": "Amiodarone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077234",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "AMIODARONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "N",
"IndicationAndUsage": "Amiodarone Hydrochloride Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone Hydrochloride Injection also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with Amiodarone Hydrochloride Injection, patients may be transferred to oral amiodarone therapy [see Dosage and Administration ( 2)]. Use Amiodarone Hydrochloride Injection for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but Amiodarone Hydrochloride Injection may be safely administered for longer periods if necessary.",
"Description": "Amiodarone Hydrochloride Injection contains Amiodarone Hydrochloride (C25H29I2NO3HCl), a class III antiarrhythmic drug. Amiodarone Hydrochloride is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone Hydrochloride has the following structural formula. Amiodarone Hydrochloride is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone Hydrochloride Injection is a sterile clear, pale-yellow micellar solution visually free from particulates. Each milliliter of the amiodarone formulation contains 50 mg of amiodarone hydrochloride, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone Hydrochloride Injection contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) [(see Dosage and Administration (2)]."
},
{
"NDCCode": "51662-1207-3",
"PackageDescription": "10 POUCH in 1 CASE (51662-1207-3) / 1 CARTON in 1 POUCH (51662-1207-2) / 1 SYRINGE, GLASS in 1 CARTON / 10 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51662-1207-03",
"ProductNDC": "51662-1207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180822",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "HF Acquisition Co. LLC, DBA Health First",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180822",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.",
"Description": "Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.1 mg of atropine sulfate monohydrate equivalent to 0.083 mg of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment 0.308 mOsmol/mL (calc.). pH 3.0 to 6.5. Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na+) and chloride (Cl-) ions. The 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. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 ∙ H2SO4 ∙ H2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water."
},
{
"NDCCode": "51662-1208-3",
"PackageDescription": "10 POUCH in 1 CASE (51662-1208-3) / 1 CARTON in 1 POUCH (51662-1208-2) / 1 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51662-1208-03",
"ProductNDC": "51662-1208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180820",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "HF Acquisition Co., LLC, DBA Health First",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221110",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.",
"Description": "Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.1 mg of atropine sulfate monohydrate equivalent to 0.083 mg of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment 0.308 mOsmol/mL (calc.). pH 3.0 to 6.5. Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na+) and chloride (Cl-) ions. The 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. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 ∙ H2SO4 ∙ H2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water."
},
{
"NDCCode": "51662-1209-3",
"PackageDescription": "10 POUCH in 1 CASE (51662-1209-3) / 1 CARTON in 1 POUCH (51662-1209-2) / 1 SYRINGE, GLASS in 1 CARTON / 10 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51662-1209-03",
"ProductNDC": "51662-1209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcium Chloride",
"NonProprietaryName": "Calcium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; INTRAVENTRICULAR",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "CALCIUM CHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221212",
"SamplePackage": "N",
"IndicationAndUsage": "10% Calcium Chloride Injection, USP is indicated (1) for the treatment of hypocalcemia in those conditions requiring a prompt increase in blood plasma calcium levels, (2) in the treatment of magnesium intoxication due to overdosage of magnesium sulfate and (3) to combat the deleterious effects of hyperkalemia as measured by electrocardiographic (ECG), pending correction of the increased potassium level in the extracellular fluid. 10% Calcium Chloride Injection, USP also may be used in cardiac resuscitation when weak or inadequate contractions return following defibrillation or when epinephrine injection has failed to strengthen myocardial contractions.",
"Description": "10% Calcium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution containing 100 mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4 mEq each of Ca++ and Cl¯) in water for injection. It is provided in a 10 mL Unit of Use Syringe to facilitate prompt intravenous injection. The solution is administered only by intravenous or intraventricular cavity injection as a calcium replenisher. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. As per USP testing, when diluted with water for injection to make a 5% solution, the pH of calcium chloride injection is 6.3 (5.5 to 7.5). May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The osmolar concentration is 2.04 mOsmol/mL (calc.). 10% Calcium Chloride Injection, USP is oxygen sensitive. Calcium Chloride, USP dihydrate is chemically designated CaCl2 · 2H2O (dihydrate) white, odorless fragments or granules freely soluble in water."
},
{
"NDCCode": "51662-1210-1",
"PackageDescription": "2 BLISTER PACK in 1 BAG (51662-1210-1) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "51662-1210-01",
"ProductNDC": "51662-1210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070974",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181130",
"SamplePackage": "N"
},
{
"NDCCode": "51662-1217-1",
"PackageDescription": "2 mL in 1 AMPULE (51662-1217-1) ",
"NDC11Code": "51662-1217-01",
"ProductNDC": "51662-1217",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083391",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180913",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Heart Failure in Adults. Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms, as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. 1.2 Atrial Fibrillation in Adults. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin has the chemical name: 3β-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide, and the following structural formula. C41H64O14 MW 780.94. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Injection is a sterile solution for slow intravenous or deep intramuscular injection. Each mL contains digoxin 250 mcg (0.25 mg), alcohol 0.1 mL, propylene glycol 0.4 mL, dibasic sodium phosphate, anhydrous 3 mg and citric acid, anhydrous 0.8 mg in Water for Injection. pH 6.7-7.3; citric acid and/or sodium phosphate added, if necessary, for pH adjustment. Dilution is not required."
},
{
"NDCCode": "51662-1217-3",
"PackageDescription": "25 POUCH in 1 CASE (51662-1217-3) / 1 mL in 1 POUCH (51662-1217-2) ",
"NDC11Code": "51662-1217-03",
"ProductNDC": "51662-1217",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083391",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210112",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Heart Failure in Adults. Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms, as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. 1.2 Atrial Fibrillation in Adults. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin has the chemical name: 3β-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide, and the following structural formula. C41H64O14 MW 780.94. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Injection is a sterile solution for slow intravenous or deep intramuscular injection. Each mL contains digoxin 250 mcg (0.25 mg), alcohol 0.1 mL, propylene glycol 0.4 mL, dibasic sodium phosphate, anhydrous 3 mg and citric acid, anhydrous 0.8 mg in Water for Injection. pH 6.7-7.3; citric acid and/or sodium phosphate added, if necessary, for pH adjustment. Dilution is not required."
},
{
"NDCCode": "51662-1219-3",
"PackageDescription": "25 POUCH in 1 CASE (51662-1219-3) / 1 mL in 1 POUCH (51662-1219-2) ",
"NDC11Code": "51662-1219-03",
"ProductNDC": "51662-1219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diphenhydramine Hydrochloride",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20180816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080817",
"LabelerName": "HF Acquisition Co. LLC, DBA Health First",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "N",
"IndicationAndUsage": "Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical. Antihistaminic. For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. Motion Sickness. For active treatment of motion sickness. Antiparkinsonism. For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents, mild cases of parkinsonism in other age groups and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.",
"Description": "Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride 50 mg and benzethonium chloride 100 mcg in Water for Injection. pH 4.0-6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment. The chemical name of diphenhydramine hydrochloride is 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. The structural formula is as follows. C17H21NO HCl MW 291.82. Diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol."
},
{
"NDCCode": "51662-1220-3",
"PackageDescription": "25 POUCH in 1 CASE (51662-1220-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1220-2) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "51662-1220-03",
"ProductNDC": "51662-1220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dopamine Hci",
"NonProprietaryName": "Dopamine Hci",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180823",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018132",
"LabelerName": "HF Acquisition Co. LLC, DBA Health First",
"SubstanceName": "DOPAMINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2024-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221110",
"SamplePackage": "N",
"IndicationAndUsage": "Dopamine HCl is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma, endotoxic septicemia, open-heart surgery, renal failure, and chronic cardiac decompensation as in congestive failure. Patients most likely to respond adequately to dopamine HCl are those in whom physiological parameters, such as urine flow, myocardial function, and blood pressure, have not undergone profound deterioration. Multiclinic trials indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with blood volume correction and dopamine HCl, the better the prognosis. Where appropriate, blood volume restoration with a suitable plasma expander or whole blood should be accomplished prior to administration of dopamine HCl. Poor Perfusion of Vital Organs – Urine flow appears to be one of the better diagnostic signs by which adequacy of vital organ perfusion can be monitored. Nevertheless, the physician should also observe the patient for signs of reversal of confusion or reversal of comatose condition. Loss of pallor, increase in toe temperature, and/or adequacy of nail bed capillary filling may also be used as indices of adequate dosage. Clinical studies have shown that when dopamine HCl is administered before urine flow has diminished to levels of approximately 0.3 mL/minute, prognosis is more favorable. Nevertheless, in a number of oliguric or anuric patients, administration of dopamine HCl has resulted in an increase in urine flow, which in some cases reached normal levels. Dopamine HCl may also increase urine flow in patients whose output is within normal limits and thus may be of value in reducing the degree of pre-existing fluid accumulation. It should be noted that at doses above those optimal for the individual patient, urine flow may decrease, necessitating reduction of dosage. Low Cardiac Output – Increased cardiac output is related to dopamine's direct inotropic effect on the myocardium. Increased cardiac output at low or moderate doses appears to be related to a favorable prognosis. Increase in cardiac output has been associated with either static or decreased systemic vascular resistance (SVR). Static or decreased SVR associated with low or moderate movements in cardiac output is believed to be a reflection of differential effects on specific vascular beds with increased resistance in peripheral beds (e.g., femoral) and concomitant decreases in mesenteric and renal vascular beds. Redistribution of blood flow parallels these changes so that an increase in cardiac output is accompanied by an increase in mesenteric and renal blood flow. In many instances the renal fraction of the total cardiac output has been found to increase. Increase in cardiac output produced by dopamine is not associated with substantial decreases in systemic vascular resistance as may occur with isoproterenol. Hypotension – Hypotension due to inadequate cardiac output can be managed by administration of low to moderate doses of dopamine HCl which have little effect on SVR. At high therapeutic doses, dopamine's alpha-adrenergic activity becomes more prominent and thus may correct hypotension due to diminished SVR. As in the case of other circulatory decompensation states, prognosis is better in patients whose blood pressure and urine flow have not undergone profound deterioration. Therefore, it is suggested that the physician administer dopamine HCl as soon as a definite trend toward decreased systolic and diastolic pressure becomes evident.",
"Description": "Dopamine, a sympathomimetic amine vasopressor, is the naturally occurring immediate precursor of norepinephrine. Dopamine hydrochloride is a white to off-white crystalline powder, which may have a slight odor of hydrochloric acid. It is freely soluble in water and soluble in alcohol. Dopamine HCl is sensitive to alkalies, iron salts, and oxidizing agents. Chemically it is designated as 4-(2-aminoethyl) pyrocatechol hydrochloride, and its molecular formula is C8H11NO2 HCl. The structural formula is. and the molecular weight is 189.64. Dopamine hydrochloride injection is a clear, practically colorless, sterile, pyrogen-free, aqueous solution of dopamine HCl for intravenous infusion after dilution. Each milliliter of the 40 mg/mL preparation contains 40 mg of dopamine hydrochloride (equivalent to 32.31 mg of dopamine base). Each milliliter of the 80 mg/mL preparation contains 80 mg of dopamine hydrochloride (equivalent to 64.62 mg of dopamine base). Each milliliter of both preparations contains the following: Sodium metabisulfite 9 mg added as an antioxidant; citric acid, anhydrous 10 mg; and sodium citrate, dihydrate 5 mg added as a buffer. May contain additional citric acid and/or sodium citrate for pH adjustment. pH is 3.3 (2.5 to 5.0). Dopamine must be diluted in an appropriate sterile parenteral solution before intravenous administration. ( See Dosage and Administration)."
},
{
"NDCCode": "51662-1221-3",
"PackageDescription": "50 POUCH in 1 CASE (51662-1221-3) > 1 mL in 1 POUCH (51662-1221-2) ",
"NDC11Code": "51662-1221-03",
"ProductNDC": "51662-1221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "ENDOTRACHEAL; INTRACARDIAC; INTRAVENOUS",
"StartMarketingDate": "20180917",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210112",
"SamplePackage": "N",
"IndicationAndUsage": "Epinephrine Injection, USP is indicated for intravenous injection in (1) treatment of acute hypersensitivity (anaphylactoid reactions to drugs, animal serums and other allergens), (2) treatment of acute asthmatic attacks to relieve bronchospasm not controlled by inhalation or subcutaneous administration of other solutions of the drug and (3) treatment and prophylaxis of cardiac arrest and attacks of transitory atrioventricular (A-V) heart block with syncopal seizures (Stokes-Adams Syndrome). In acute attacks of ventricular standstill, physical measures should be applied first. When external cardiac compression and attempts to restore the circulation by electrical defibrillation or use of a pacemaker fail, intracardiac puncture and intramyocardial injection of epinephrine may be effective.",
"Description": "Epinephrine Injection, USP is a sterile, nonpyrogenic solution administered parenterally by the intravenous or intracardiac (left ventricular chamber) routes, or via endotracheal tube into the bronchial tree. Each milliliter (mL) contains epinephrine 0.1 mg; sodium chloride 8.16 mg; sodium metabisulfite added 0.46 mg; citric acid, anhydrous 2 mg and sodium citrate, dihydrate 0.6 mg added as buffers. May contain additional citric acid and/or sodium citrate for pH adjustment. pH 3.3 (2.2 to 5.0). Epinephrine Injection, USP is oxygen sensitive. The solution contains no bacteriostat or antimicrobial agent and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Epinephrine Injection, USP is a parenteral adrenergic (sympathomimetic) agent and cardiac stimulant. The drug belongs to the group of endogenous compounds known as catecholamines. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Epinephrine, USP is chemically designated 4-[1-hydroxy-2-(methylamino) ethyl]-1, 2 benzenediol, a white, microcrystalline powder. With acids, it forms salts that are freely soluble in water. Epinephrine has the following structural formula."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>51662-1556-2</NDCCode>
<PackageDescription>1 AMPULE in 1 POUCH (51662-1556-2) / 1 mL in 1 AMPULE (51662-1556-1) </PackageDescription>
<NDC11Code>51662-1556-02</NDC11Code>
<ProductNDC>51662-1556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylergonovine Maleate</ProprietaryName>
<NonProprietaryName>Methylergonovine Maleate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040889</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>METHYLERGONOVINE MALEATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Following delivery of the placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
<Description>Methylergonovine Maleate Injection, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Injection, USP is available in sterile ampules of 1 mL, containing 0.2 mg methylergonovine maleate for intramuscular or intravenous injection. Ampules, 1 mL, clear, colorless solution. Active Ingredients: methylergonovine maleate, USP, 0.2 mg. Inactive Ingredients: maleic acid, 0.10 mg; sodium chloride, 7.0 mg; water for injection, qs to 1 mL. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9,10-didehydro-N-[l-(hydroxymethyl)propyl ]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is. C20H25N3O2∙C4H4O4 Mol. wt. - 455.51.</Description>
</NDC>
<NDC>
<NDCCode>51662-1556-1</NDCCode>
<PackageDescription>1 mL in 1 AMPULE (51662-1556-1) </PackageDescription>
<NDC11Code>51662-1556-01</NDC11Code>
<ProductNDC>51662-1556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylergonovine Maleate</ProprietaryName>
<NonProprietaryName>Methylergonovine Maleate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040889</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>METHYLERGONOVINE MALEATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Following delivery of the placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
<Description>Methylergonovine Maleate Injection, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Injection, USP is available in sterile ampules of 1 mL, containing 0.2 mg methylergonovine maleate for intramuscular or intravenous injection. Ampules, 1 mL, clear, colorless solution. Active Ingredients: methylergonovine maleate, USP, 0.2 mg. Inactive Ingredients: maleic acid, 0.10 mg; sodium chloride, 7.0 mg; water for injection, qs to 1 mL. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9,10-didehydro-N-[l-(hydroxymethyl)propyl ]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is. C20H25N3O2∙C4H4O4 Mol. wt. - 455.51.</Description>
</NDC>
<NDC>
<NDCCode>22840-1556-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-1556-2) </PackageDescription>
<NDC11Code>22840-1556-02</NDC11Code>
<ProductNDC>22840-1556</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Gum Arabic</ProprietaryName>
<NonProprietaryName>Acacia Senegal</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>ACACIA</SubstanceName>
<StrengthNumber>.01</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens.</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>24286-1556-2</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (24286-1556-2) / 71 g in 1 TUBE</PackageDescription>
<NDC11Code>24286-1556-02</NDC11Code>
<ProductNDC>24286-1556</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Earths Care Acne Treatment Mask</ProprietaryName>
<NonProprietaryName>Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>DLC Laboratories, Inc.</LabelerName>
<SubstanceName>SULFUR</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the treatment of acne: 1 penetrates the pores and dries and clears pimples and blackheads, 2 helps to keep new pimples and black heads from forming. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24286-1556-3</NDCCode>
<PackageDescription>2.8 g in 1 POUCH (24286-1556-3) </PackageDescription>
<NDC11Code>24286-1556-03</NDC11Code>
<ProductNDC>24286-1556</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Earths Care Acne Treatment Mask</ProprietaryName>
<NonProprietaryName>Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>DLC Laboratories, Inc.</LabelerName>
<SubstanceName>SULFUR</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the treatment of acne: 1 penetrates the pores and dries and clears pimples and blackheads, 2 helps to keep new pimples and black heads from forming. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-1556-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-1556-2)</PackageDescription>
<NDC11Code>36987-1556-02</NDC11Code>
<ProductNDC>36987-1556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pecan Nut</ProprietaryName>
<NonProprietaryName>Pecan Nut</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>PECAN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-1556-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-1556-2) </PackageDescription>
<NDC11Code>37662-1556-02</NDC11Code>
<ProductNDC>37662-1556</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Manganum Sulphuricum</ProprietaryName>
<NonProprietaryName>Manganum Sulphuricum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>MANGANESE SULFATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-1556-2</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (50090-1556-2)</PackageDescription>
<NDC11Code>50090-1556-02</NDC11Code>
<ProductNDC>50090-1556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67296-1556-2</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (67296-1556-2) </PackageDescription>
<NDC11Code>67296-1556-02</NDC11Code>
<ProductNDC>67296-1556</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dok</ProprietaryName>
<NonProprietaryName>Dok</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70518-1556-1</NDCCode>
<PackageDescription>100 POUCH in 1 BOX (70518-1556-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-1556-2) </PackageDescription>
<NDC11Code>70518-1556-01</NDC11Code>
<ProductNDC>70518-1556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203730</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Divalproex sodium extended-release tablets are indicated for: 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1)., 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2). , 3 Prophylaxis of migraine headaches (1.3). .</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium extended-release tablets USP, 250 mg and 500 mg are for oral administration. Divalproex sodium extended-release tablets, USP contain divalproex sodium, USP in a once-a-day extended-release formulation equivalent to 250 and 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium extended-release tablets USP, 250 mg and 500 mg: ammonium hydroxide, ethyl acrylate and methyl methacrylate co-polymer dispersion, hypromellose, iron oxide, isopropyl alcohol, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, polyvinyl alcohol, propylene glycol, shellac, silicon dioxide, talc, and titanium dioxide. Meets USP Dissolution Test 13.</Description>
</NDC>
<NDC>
<NDCCode>71335-1556-2</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (71335-1556-2) </PackageDescription>
<NDC11Code>71335-1556-02</NDC11Code>
<ProductNDC>71335-1556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19890228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072575</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0115-1556-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1556-01) </PackageDescription>
<NDC11Code>00115-1556-01</NDC11Code>
<ProductNDC>0115-1556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022272</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone HCl extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in: 1 Adults; and, 2 Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent.</IndicationAndUsage>
<Description>Oxycodone HCl extended-release tablets are an opioid agonist supplied in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt. The structural formula for oxycodone hydrochloride is as follows. C18 H21 NO4 ∙ HCl MW 351.83. The chemical name is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). The 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg tablets contain the following inactive ingredients: butylated hydroxytoluene (BHT), hypromellose, polyethylene glycol 400, polyethylene oxide, magnesium stearate, titanium dioxide. The 10 mg tablets also contain hydroxypropyl cellulose. The 15 mg tablets also contain black iron oxide, yellow iron oxide, and red iron oxide. The 20 mg tablets also contain polysorbate 80 and red iron oxide. The 30 mg tablets also contain polysorbate 80, red iron oxide, yellow iron oxide, and black iron oxide. The 40 mg tablets also contain polysorbate 80 and yellow iron oxide. The 60 mg tablets also contain polysorbate 80, red iron oxide and black iron oxide. The 80 mg tablets also contain hydroxypropyl cellulose, yellow iron oxide and FD&C Blue #2/Indigo Carmine Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0781-1556-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0781-1556-01) </PackageDescription>
<NDC11Code>00781-1556-01</NDC11Code>
<ProductNDC>0781-1556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Dinitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Dinitrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086223</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<SubstanceName>ISOSORBIDE DINITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is. The organic nitrates are vasodilators, active on both arteries and veins. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate is available as 5 mg, 10 mg, and 20 mg tablets for oral administration. Inactive ingredients: lactose (monohydrate), magnesium stearate, microcrystalline cellulose. The 5 mg also contains FD & C Red #40 Aluminum Lake. The 20 mg also contains D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, and FD & C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0781-1556-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0781-1556-05) </PackageDescription>
<NDC11Code>00781-1556-05</NDC11Code>
<ProductNDC>0781-1556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Dinitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Dinitrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086223</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<SubstanceName>ISOSORBIDE DINITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is. The organic nitrates are vasodilators, active on both arteries and veins. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate is available as 5 mg, 10 mg, and 20 mg tablets for oral administration. Inactive ingredients: lactose (monohydrate), magnesium stearate, microcrystalline cellulose. The 5 mg also contains FD & C Red #40 Aluminum Lake. The 20 mg also contains D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, and FD & C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0781-1556-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (0781-1556-10) </PackageDescription>
<NDC11Code>00781-1556-10</NDC11Code>
<ProductNDC>0781-1556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Dinitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Dinitrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086223</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<SubstanceName>ISOSORBIDE DINITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is. The organic nitrates are vasodilators, active on both arteries and veins. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate is available as 5 mg, 10 mg, and 20 mg tablets for oral administration. Inactive ingredients: lactose (monohydrate), magnesium stearate, microcrystalline cellulose. The 5 mg also contains FD & C Red #40 Aluminum Lake. The 20 mg also contains D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, and FD & C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>53002-1556-0</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (53002-1556-0) </PackageDescription>
<NDC11Code>53002-1556-00</NDC11Code>
<ProductNDC>53002-1556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078332</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: : 1 mild to severe chronic heart failure (1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose.Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>53002-1556-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (53002-1556-3) </PackageDescription>
<NDC11Code>53002-1556-03</NDC11Code>
<ProductNDC>53002-1556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078332</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: : 1 mild to severe chronic heart failure (1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 3 hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of lactose monohydrate, colloidal silicon dioxide, crospovidone, povidone, sucrose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide, and hypromellose.Carvedilol USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51662-1201-1</NDCCode>
<PackageDescription>2 mL in 1 VIAL (51662-1201-1) </PackageDescription>
<NDC11Code>51662-1201-01</NDC11Code>
<ProductNDC>51662-1201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adenosine Injection, 6mg/2ml (3mg/ml) Vial</ProprietaryName>
<NonProprietaryName>Adenosine Injection, 6mg/2ml (3mg/ml) Vial</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078076</ApplicationNumber>
<LabelerName>HF Acquisition Co. LLC, DBA Health First</LabelerName>
<SubstanceName>ADENOSINE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adenosine injection is indicated for the following. Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine administration. It is important to be sure the adenosine solution actually reaches the systemic circulation ( See Dosage and Administration). Adenosine does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine administration.</IndicationAndUsage>
<Description>Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-β-D-ribofuranosyl-9-H-purine with the structural formula. Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine injection is a sterile, nonpyrogenic solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine, and 9 mg sodium chloride, in Water for Injection. The pH of the solution is between 4.5 and 7.5.</Description>
</NDC>
<NDC>
<NDCCode>51662-1201-3</NDCCode>
<PackageDescription>20 POUCH in 1 CASE (51662-1201-3) > 1 mL in 1 POUCH (51662-1201-2) </PackageDescription>
<NDC11Code>51662-1201-03</NDC11Code>
<ProductNDC>51662-1201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adenosine Injection, 6mg/2ml (3mg/ml) Vial</ProprietaryName>
<NonProprietaryName>Adenosine Injection, 6mg/2ml (3mg/ml) Vial</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078076</ApplicationNumber>
<LabelerName>HF Acquisition Co. LLC, DBA Health First</LabelerName>
<SubstanceName>ADENOSINE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51662-1204-3</NDCCode>
<PackageDescription>25 POUCH in 1 CASE (51662-1204-3) / 1 mL in 1 POUCH (51662-1204-2) </PackageDescription>
<NDC11Code>51662-1204-03</NDC11Code>
<ProductNDC>51662-1204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminophylline</ProprietaryName>
<NonProprietaryName>Aminophylline</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087242</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>AMINOPHYLLINE DIHYDRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Intravenous theophylline is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.</IndicationAndUsage>
<Description>Aminophylline Injection, USP is a sterile, nonpyrogenic solution of aminophylline in water for injection. Aminophylline (dihydrate) is approximately 79% of anhydrous theophylline by weight. Aminophylline Injection is administered by slow intravenous injection or diluted and administered by intravenous infusion. The solution contains no bacteriostat or antimicrobial agent and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Aminophylline is a 2:1 complex of theophylline and ethylenediamine. Theophylline is structurally classified as a methylxanthine. Aminophylline occurs as a white or slightly yellowish granule or powder, with a slight ammoniacal odor. Aminophylline has the chemical name 1H-Purine-2, 6-dione, 3,7-dihydro-1,3-dimethyl-, compound with 1,2-ethanediamine (2:1). The structural formula of aminophylline (dihydrate) is as follows. The molecular formula of aminophylline dihydrate is C16H24N10O4 2(H2O) with a molecular weight of 456.46. Aminophylline Injection, USP contains aminophylline (calculated as the dihydrate) 25 mg/mL (equivalent to 19.7 mg/mL anhydrous theophylline) prepared with the aid of ethylenediamine. The solution may contain an excess of ethylenediamine for pH adjustment. pH is 8.8 (8.6 to 9.0). The osmolar concentration is 0.17 mOsmol/mL (calc.).</Description>
</NDC>
<NDC>
<NDCCode>51662-1205-3</NDCCode>
<PackageDescription>25 POUCH in 1 CASE (51662-1205-3) / 1 mL in 1 POUCH (51662-1205-2) </PackageDescription>
<NDC11Code>51662-1205-03</NDC11Code>
<ProductNDC>51662-1205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amiodarone Hydrochloride</ProprietaryName>
<NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077234</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>AMIODARONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amiodarone Hydrochloride Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone Hydrochloride Injection also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with Amiodarone Hydrochloride Injection, patients may be transferred to oral amiodarone therapy [see Dosage and Administration ( 2)]. Use Amiodarone Hydrochloride Injection for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but Amiodarone Hydrochloride Injection may be safely administered for longer periods if necessary.</IndicationAndUsage>
<Description>Amiodarone Hydrochloride Injection contains Amiodarone Hydrochloride (C25H29I2NO3HCl), a class III antiarrhythmic drug. Amiodarone Hydrochloride is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone Hydrochloride has the following structural formula. Amiodarone Hydrochloride is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone Hydrochloride Injection is a sterile clear, pale-yellow micellar solution visually free from particulates. Each milliliter of the amiodarone formulation contains 50 mg of amiodarone hydrochloride, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone Hydrochloride Injection contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) [(see Dosage and Administration (2)].</Description>
</NDC>
<NDC>
<NDCCode>51662-1207-3</NDCCode>
<PackageDescription>10 POUCH in 1 CASE (51662-1207-3) / 1 CARTON in 1 POUCH (51662-1207-2) / 1 SYRINGE, GLASS in 1 CARTON / 10 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>51662-1207-03</NDC11Code>
<ProductNDC>51662-1207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180822</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>HF Acquisition Co. LLC, DBA Health First</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.</IndicationAndUsage>
<Description>Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.1 mg of atropine sulfate monohydrate equivalent to 0.083 mg of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment 0.308 mOsmol/mL (calc.). pH 3.0 to 6.5. Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na+) and chloride (Cl-) ions. The 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. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 ∙ H2SO4 ∙ H2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>51662-1208-3</NDCCode>
<PackageDescription>10 POUCH in 1 CASE (51662-1208-3) / 1 CARTON in 1 POUCH (51662-1208-2) / 1 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>51662-1208-03</NDC11Code>
<ProductNDC>51662-1208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180820</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>HF Acquisition Co., LLC, DBA Health First</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.</IndicationAndUsage>
<Description>Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.1 mg of atropine sulfate monohydrate equivalent to 0.083 mg of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment 0.308 mOsmol/mL (calc.). pH 3.0 to 6.5. Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na+) and chloride (Cl-) ions. The 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. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 ∙ H2SO4 ∙ H2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1-hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>51662-1209-3</NDCCode>
<PackageDescription>10 POUCH in 1 CASE (51662-1209-3) / 1 CARTON in 1 POUCH (51662-1209-2) / 1 SYRINGE, GLASS in 1 CARTON / 10 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>51662-1209-03</NDC11Code>
<ProductNDC>51662-1209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcium Chloride</ProprietaryName>
<NonProprietaryName>Calcium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; INTRAVENTRICULAR</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>10% Calcium Chloride Injection, USP is indicated (1) for the treatment of hypocalcemia in those conditions requiring a prompt increase in blood plasma calcium levels, (2) in the treatment of magnesium intoxication due to overdosage of magnesium sulfate and (3) to combat the deleterious effects of hyperkalemia as measured by electrocardiographic (ECG), pending correction of the increased potassium level in the extracellular fluid. 10% Calcium Chloride Injection, USP also may be used in cardiac resuscitation when weak or inadequate contractions return following defibrillation or when epinephrine injection has failed to strengthen myocardial contractions.</IndicationAndUsage>
<Description>10% Calcium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution containing 100 mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4 mEq each of Ca++ and Cl¯) in water for injection. It is provided in a 10 mL Unit of Use Syringe to facilitate prompt intravenous injection. The solution is administered only by intravenous or intraventricular cavity injection as a calcium replenisher. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. As per USP testing, when diluted with water for injection to make a 5% solution, the pH of calcium chloride injection is 6.3 (5.5 to 7.5). May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The osmolar concentration is 2.04 mOsmol/mL (calc.). 10% Calcium Chloride Injection, USP is oxygen sensitive. Calcium Chloride, USP dihydrate is chemically designated CaCl2 · 2H2O (dihydrate) white, odorless fragments or granules freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>51662-1210-1</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 BAG (51662-1210-1) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51662-1210-01</NDC11Code>
<ProductNDC>51662-1210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070974</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51662-1217-1</NDCCode>
<PackageDescription>2 mL in 1 AMPULE (51662-1217-1) </PackageDescription>
<NDC11Code>51662-1217-01</NDC11Code>
<ProductNDC>51662-1217</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083391</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Heart Failure in Adults. Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms, as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. 1.2 Atrial Fibrillation in Adults. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin has the chemical name: 3β-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide, and the following structural formula. C41H64O14 MW 780.94. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Injection is a sterile solution for slow intravenous or deep intramuscular injection. Each mL contains digoxin 250 mcg (0.25 mg), alcohol 0.1 mL, propylene glycol 0.4 mL, dibasic sodium phosphate, anhydrous 3 mg and citric acid, anhydrous 0.8 mg in Water for Injection. pH 6.7-7.3; citric acid and/or sodium phosphate added, if necessary, for pH adjustment. Dilution is not required.</Description>
</NDC>
<NDC>
<NDCCode>51662-1217-3</NDCCode>
<PackageDescription>25 POUCH in 1 CASE (51662-1217-3) / 1 mL in 1 POUCH (51662-1217-2) </PackageDescription>
<NDC11Code>51662-1217-03</NDC11Code>
<ProductNDC>51662-1217</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083391</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Heart Failure in Adults. Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms, as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. 1.2 Atrial Fibrillation in Adults. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin has the chemical name: 3β-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide, and the following structural formula. C41H64O14 MW 780.94. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Injection is a sterile solution for slow intravenous or deep intramuscular injection. Each mL contains digoxin 250 mcg (0.25 mg), alcohol 0.1 mL, propylene glycol 0.4 mL, dibasic sodium phosphate, anhydrous 3 mg and citric acid, anhydrous 0.8 mg in Water for Injection. pH 6.7-7.3; citric acid and/or sodium phosphate added, if necessary, for pH adjustment. Dilution is not required.</Description>
</NDC>
<NDC>
<NDCCode>51662-1219-3</NDCCode>
<PackageDescription>25 POUCH in 1 CASE (51662-1219-3) / 1 mL in 1 POUCH (51662-1219-2) </PackageDescription>
<NDC11Code>51662-1219-03</NDC11Code>
<ProductNDC>51662-1219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diphenhydramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20180816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080817</ApplicationNumber>
<LabelerName>HF Acquisition Co. LLC, DBA Health First</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical. Antihistaminic. For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. Motion Sickness. For active treatment of motion sickness. Antiparkinsonism. For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents, mild cases of parkinsonism in other age groups and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.</IndicationAndUsage>
<Description>Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride 50 mg and benzethonium chloride 100 mcg in Water for Injection. pH 4.0-6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment. The chemical name of diphenhydramine hydrochloride is 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. The structural formula is as follows. C17H21NO HCl MW 291.82. Diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>51662-1220-3</NDCCode>
<PackageDescription>25 POUCH in 1 CASE (51662-1220-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1220-2) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>51662-1220-03</NDC11Code>
<ProductNDC>51662-1220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dopamine Hci</ProprietaryName>
<NonProprietaryName>Dopamine Hci</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180823</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018132</ApplicationNumber>
<LabelerName>HF Acquisition Co. LLC, DBA Health First</LabelerName>
<SubstanceName>DOPAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dopamine HCl is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma, endotoxic septicemia, open-heart surgery, renal failure, and chronic cardiac decompensation as in congestive failure. Patients most likely to respond adequately to dopamine HCl are those in whom physiological parameters, such as urine flow, myocardial function, and blood pressure, have not undergone profound deterioration. Multiclinic trials indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with blood volume correction and dopamine HCl, the better the prognosis. Where appropriate, blood volume restoration with a suitable plasma expander or whole blood should be accomplished prior to administration of dopamine HCl. Poor Perfusion of Vital Organs – Urine flow appears to be one of the better diagnostic signs by which adequacy of vital organ perfusion can be monitored. Nevertheless, the physician should also observe the patient for signs of reversal of confusion or reversal of comatose condition. Loss of pallor, increase in toe temperature, and/or adequacy of nail bed capillary filling may also be used as indices of adequate dosage. Clinical studies have shown that when dopamine HCl is administered before urine flow has diminished to levels of approximately 0.3 mL/minute, prognosis is more favorable. Nevertheless, in a number of oliguric or anuric patients, administration of dopamine HCl has resulted in an increase in urine flow, which in some cases reached normal levels. Dopamine HCl may also increase urine flow in patients whose output is within normal limits and thus may be of value in reducing the degree of pre-existing fluid accumulation. It should be noted that at doses above those optimal for the individual patient, urine flow may decrease, necessitating reduction of dosage. Low Cardiac Output – Increased cardiac output is related to dopamine's direct inotropic effect on the myocardium. Increased cardiac output at low or moderate doses appears to be related to a favorable prognosis. Increase in cardiac output has been associated with either static or decreased systemic vascular resistance (SVR). Static or decreased SVR associated with low or moderate movements in cardiac output is believed to be a reflection of differential effects on specific vascular beds with increased resistance in peripheral beds (e.g., femoral) and concomitant decreases in mesenteric and renal vascular beds. Redistribution of blood flow parallels these changes so that an increase in cardiac output is accompanied by an increase in mesenteric and renal blood flow. In many instances the renal fraction of the total cardiac output has been found to increase. Increase in cardiac output produced by dopamine is not associated with substantial decreases in systemic vascular resistance as may occur with isoproterenol. Hypotension – Hypotension due to inadequate cardiac output can be managed by administration of low to moderate doses of dopamine HCl which have little effect on SVR. At high therapeutic doses, dopamine's alpha-adrenergic activity becomes more prominent and thus may correct hypotension due to diminished SVR. As in the case of other circulatory decompensation states, prognosis is better in patients whose blood pressure and urine flow have not undergone profound deterioration. Therefore, it is suggested that the physician administer dopamine HCl as soon as a definite trend toward decreased systolic and diastolic pressure becomes evident.</IndicationAndUsage>
<Description>Dopamine, a sympathomimetic amine vasopressor, is the naturally occurring immediate precursor of norepinephrine. Dopamine hydrochloride is a white to off-white crystalline powder, which may have a slight odor of hydrochloric acid. It is freely soluble in water and soluble in alcohol. Dopamine HCl is sensitive to alkalies, iron salts, and oxidizing agents. Chemically it is designated as 4-(2-aminoethyl) pyrocatechol hydrochloride, and its molecular formula is C8H11NO2 HCl. The structural formula is. and the molecular weight is 189.64. Dopamine hydrochloride injection is a clear, practically colorless, sterile, pyrogen-free, aqueous solution of dopamine HCl for intravenous infusion after dilution. Each milliliter of the 40 mg/mL preparation contains 40 mg of dopamine hydrochloride (equivalent to 32.31 mg of dopamine base). Each milliliter of the 80 mg/mL preparation contains 80 mg of dopamine hydrochloride (equivalent to 64.62 mg of dopamine base). Each milliliter of both preparations contains the following: Sodium metabisulfite 9 mg added as an antioxidant; citric acid, anhydrous 10 mg; and sodium citrate, dihydrate 5 mg added as a buffer. May contain additional citric acid and/or sodium citrate for pH adjustment. pH is 3.3 (2.5 to 5.0). Dopamine must be diluted in an appropriate sterile parenteral solution before intravenous administration. ( See Dosage and Administration).</Description>
</NDC>
<NDC>
<NDCCode>51662-1221-3</NDCCode>
<PackageDescription>50 POUCH in 1 CASE (51662-1221-3) > 1 mL in 1 POUCH (51662-1221-2) </PackageDescription>
<NDC11Code>51662-1221-03</NDC11Code>
<ProductNDC>51662-1221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>ENDOTRACHEAL; INTRACARDIAC; INTRAVENOUS</RouteName>
<StartMarketingDate>20180917</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Epinephrine Injection, USP is indicated for intravenous injection in (1) treatment of acute hypersensitivity (anaphylactoid reactions to drugs, animal serums and other allergens), (2) treatment of acute asthmatic attacks to relieve bronchospasm not controlled by inhalation or subcutaneous administration of other solutions of the drug and (3) treatment and prophylaxis of cardiac arrest and attacks of transitory atrioventricular (A-V) heart block with syncopal seizures (Stokes-Adams Syndrome). In acute attacks of ventricular standstill, physical measures should be applied first. When external cardiac compression and attempts to restore the circulation by electrical defibrillation or use of a pacemaker fail, intracardiac puncture and intramyocardial injection of epinephrine may be effective.</IndicationAndUsage>
<Description>Epinephrine Injection, USP is a sterile, nonpyrogenic solution administered parenterally by the intravenous or intracardiac (left ventricular chamber) routes, or via endotracheal tube into the bronchial tree. Each milliliter (mL) contains epinephrine 0.1 mg; sodium chloride 8.16 mg; sodium metabisulfite added 0.46 mg; citric acid, anhydrous 2 mg and sodium citrate, dihydrate 0.6 mg added as buffers. May contain additional citric acid and/or sodium citrate for pH adjustment. pH 3.3 (2.2 to 5.0). Epinephrine Injection, USP is oxygen sensitive. The solution contains no bacteriostat or antimicrobial agent and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Epinephrine Injection, USP is a parenteral adrenergic (sympathomimetic) agent and cardiac stimulant. The drug belongs to the group of endogenous compounds known as catecholamines. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Epinephrine, USP is chemically designated 4-[1-hydroxy-2-(methylamino) ethyl]-1, 2 benzenediol, a white, microcrystalline powder. With acids, it forms salts that are freely soluble in water. Epinephrine has the following structural formula.</Description>
</NDC>
</NDCList>