{
"NDC": [
{
"NDCCode": "0527-1333-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0527-1333-01) ",
"NDC11Code": "00527-1333-01",
"ProductNDC": "0527-1333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077241",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210922",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "0115-1333-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1333-01)",
"NDC11Code": "00115-1333-01",
"ProductNDC": "0115-1333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131217",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021303",
"LabelerName": "Global Pharmaceuticals, Division of Impax Laboratories Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE",
"StrengthNumber": "7.5; 7.5; 7.5; 7.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules (MAS-ER Capsules), a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). (1): 1 Children (ages 6-12): Efficacy was established in one 3-week outpatient, controlled trial and one analogue classroom, controlled trial in children with ADHD. (14) , 2 Adolescents (ages 13-17): Efficacy was established in one 4-week controlled trial in adolescents with ADHD. (14) , 3 Adults: Efficacy was established in one 4-week controlled trial in adults with ADHD. (14).",
"Description": "MAS-ER Capsules are a once daily extended-release, single-entity amphetamine product. MAS-ER Capsules combine the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d,l-amphetamine aspartate monohydrate. The MAS-ER Capsules contain two types of drug-containing beads designed to give a double-pulsed delivery of amphetamines, which prolongs the release of amphetamine from MAS-ER Capsules compared to the conventional ADDERALL® (immediate-release) tablet formulation."
},
{
"NDCCode": "0143-1333-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (0143-1333-01)",
"NDC11Code": "00143-1333-01",
"ProductNDC": "0143-1333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20001005",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075361",
"LabelerName": "West-ward Pharmaceutical Corp",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0363-1333-01",
"PackageDescription": "1 TUBE in 1 CARTON (0363-1333-01) / 28 g in 1 TUBE",
"NDC11Code": "00363-1333-01",
"ProductNDC": "0363-1333",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250306",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Walgreens Co.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250306",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: 1 eczema, 2 insect bites, 3 poison ivy, 4 poison oak, 5 poison sumac, 6 soaps, 7 jewelry, 8 detergents, 9 cosmetics, 10 psoriasis, 11 seborrheic dermatitis, 12 for external genital, feminine and anal itching, 13 other uses of this product should be only under the advice and supervision of a doctor."
},
{
"NDCCode": "36987-1333-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-1333-1)",
"NDC11Code": "36987-1333-01",
"ProductNDC": "36987-1333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Grapefruit",
"NonProprietaryName": "Grapefruit",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "GRAPEFRUIT",
"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],Fruit 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": "37662-1333-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-1333-1) ",
"NDC11Code": "37662-1333-01",
"ProductNDC": "37662-1333",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zincum Carbonicum",
"NonProprietaryName": "Zincum Carbonicum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220812",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "ZINC CARBONATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2022-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220812",
"SamplePackage": "N"
},
{
"NDCCode": "43742-1333-1",
"PackageDescription": "126 g in 1 BOTTLE, PUMP (43742-1333-1) ",
"NDC11Code": "43742-1333-01",
"ProductNDC": "43742-1333",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trauma Relief",
"NonProprietaryName": "Chamomilla, Echinacea (angustifolia), Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Calendula Officinalis, Arnica Montana, Belladonna, Bellis Perennis, Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos, Symphytum Officinale, Rhus Tox, Bryonia (alba), Hepar Sulphuris Calcareum, Carbo Vegetabilis",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181207",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "MATRICARIA CHAMOMILLA WHOLE; ECHINACEA ANGUSTIFOLIA WHOLE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM WHOLE; ACHILLEA MILLEFOLIUM WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA WHOLE; ATROPA BELLADONNA; BELLIS PERENNIS WHOLE; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; COMFREY ROOT; TOXICODENDRON PUBESCENS LEAF; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ACTIVATED CHARCOAL",
"StrengthNumber": "3; 3; 3; 3; 3; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 12",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181207",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of strains, sprains, and joint pain.**. **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "48951-1333-1",
"PackageDescription": "10 AMPULE in 1 BOX (48951-1333-1) > 1 mL in 1 AMPULE",
"NDC11Code": "48951-1333-01",
"ProductNDC": "48951-1333",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica E Pl. Tota 10x Special Order",
"NonProprietaryName": "Arnica E Pl. Tota 10x Special Order",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "10",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE."
},
{
"NDCCode": "50090-1333-1",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50090-1333-1) ",
"NDC11Code": "50090-1333-01",
"ProductNDC": "50090-1333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220310",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
},
{
"NDCCode": "51662-1333-1",
"PackageDescription": "250 mL in 1 BAG (51662-1333-1) ",
"NDC11Code": "51662-1333-01",
"ProductNDC": "51662-1333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Intralipid",
"NonProprietaryName": "Intralipid",
"DosageFormName": "EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181221",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018449",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "SOYBEAN OIL",
"StrengthNumber": "20",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Lipid Emulsion [EPC], Lipids [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Intralipid® 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source of essential fatty acids for prevention of EFAD.",
"Description": "Intralipid® 20% (A 20% Intravenous Fat Emulsion) is a sterile, non-pyrogenic fat emulsion prepared for intravenous administration as a source of calories and essential fatty acids. It is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and Water for Injection. In addition, sodium hydroxide has been added to adjust the pH so that the final product pH is 8. pH range is 6 to 8.9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. where. . . and. are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic acid (44-62%), oleic acid (19-30%), palmitic acid (7-14%), α-linolenic acid (4-11%) and stearic acid (1.4-5.5%).1 These fatty acids have the following chemical and structural formulas. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure. and. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula. Intralipid® 20% (A 20% Intravenous Fat Emulsion) has an osmolality of approximately 350 mOsmol/kg water (which represents 260 mOsmol/L of emulsion) and contains emulsified fat particles of approximately 0.5 micron size. The total caloric value, including fat, phospholipid and glycerin, is 2.0 kcal per mL of Intralipid® 20%. The phospholipids present contribute 47 milligrams or approximately 1.5 mmol of phosphorus per 100 mL of the emulsion. The primary plastic container (Biofine), is made from multilayered film specifically designed for parenteral nutrition drug products. The film is polypropylene based comprising three co-extruded layers. It contains no plasticizers and exhibits virtually no leachables. The container does not contain DEHP (di(2-ethylhexyl)phthalate) or PVC. The container is nontoxic and biologically inert. This product is not made with natural rubber latex. The container-emulsion unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary."
},
{
"NDCCode": "60505-1333-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (60505-1333-1)",
"NDC11Code": "60505-1333-01",
"ProductNDC": "60505-1333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077741",
"LabelerName": "Apotex Corp.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "67296-1333-1",
"PackageDescription": "10 TABLET in 1 BOTTLE (67296-1333-1) ",
"NDC11Code": "67296-1333-01",
"ProductNDC": "67296-1333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202991",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "325; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160412",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets, USP for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):. have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone bitartrate and acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. [hydrocodone structure]. C18H21NO3C4H6O62½H2O MW = 494.490. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. [acetaminophen structure]. C8H9NO2 MW = 151.16. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP, 5 mg/ 325 mg contains: Hydrocodone Bitartrate ………………....5 mg Acetaminophen ………………….…....325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP, 7.5 mg/ 325 mg contains: Hydrocodone Bitartrate ……………….7.5 mg Acetaminophen ……………………….325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP, 10 mg/ 325 mg contains: Hydrocodone Bitartrate …………….….10 mg Acetaminophen …………………….....325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch, crospovidone, magnesium stearate, povidone, and stearic acid. Meets USP Dissolution Test 1."
},
{
"NDCCode": "71335-1333-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (71335-1333-1) ",
"NDC11Code": "71335-1333-01",
"ProductNDC": "71335-1333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077210",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220209",
"SamplePackage": "N",
"IndicationAndUsage": "Monotherapy and Combination Therapy. Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)]. Important Limitations of Use. Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
"Description": "Pioglitazone Tablets, USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. C19H20N2O3SHCl M.W. 392.90. Pioglitazone hydrochloride, USP is an odorless white crystalline powder. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets USP are available for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, and mannitol."
},
{
"NDCCode": "0406-1333-05",
"PackageDescription": ".5 kg in 1 BOTTLE (0406-1333-05) ",
"NDC11Code": "00406-1333-05",
"ProductNDC": "0406-1333",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131120",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SpecGx LLC",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CII",
"Status": "Unfinished",
"LastUpdate": "2024-08-29",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20-NOV-13",
"EndMarketingDatePackage": "01-MAR-31"
},
{
"NDCCode": "0406-1333-40",
"PackageDescription": ".1 kg in 1 BOTTLE, GLASS (0406-1333-40) ",
"NDC11Code": "00406-1333-40",
"ProductNDC": "0406-1333",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131120",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SpecGx LLC",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CII",
"Status": "Unfinished",
"LastUpdate": "2025-01-02",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "01-JAN-25"
},
{
"NDCCode": "0406-1333-41",
"PackageDescription": "5 kg in 1 PAIL (0406-1333-41) ",
"NDC11Code": "00406-1333-41",
"ProductNDC": "0406-1333",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20131120",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SpecGx LLC",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CII",
"Status": "Unfinished",
"LastUpdate": "2025-01-02",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "01-JAN-25"
},
{
"NDCCode": "0527-0586-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0527-0586-01) ",
"NDC11Code": "00527-0586-01",
"ProductNDC": "0527-0586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19740930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084285",
"LabelerName": "Lannett Company, LLC",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19740930",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine Hydrochloride Capsules, USP for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, D&C Red No. 28, and FD&C Blue No. 1. , 2 Dicyclomine Hydrochloride Tablets, USP for oral use contain 20 mg dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: acacia, pregelatinized starch, anhydrous lactose, compressible sugar, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, stearic acid, and FD&C Blue No.1 Aluminum Lake."
},
{
"NDCCode": "0527-0597-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0527-0597-01) ",
"NDC11Code": "00527-0597-01",
"ProductNDC": "0527-0597",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087022",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20071201",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake."
},
{
"NDCCode": "0527-1050-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0527-1050-01) ",
"NDC11Code": "00527-1050-01",
"ProductNDC": "0527-1050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetazolamide",
"NonProprietaryName": "Acetazolamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19780331",
"EndMarketingDate": "20221031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084840",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "ACETAZOLAMIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19780331",
"EndMarketingDatePackage": "20221031",
"SamplePackage": "N"
},
{
"NDCCode": "0527-1109-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0527-1109-01) ",
"NDC11Code": "00527-1109-01",
"ProductNDC": "0527-1109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isoniazid",
"NonProprietaryName": "Isoniazid",
"DosageFormName": "TABLET",
"RouteName": "ORAL; ORAL",
"StartMarketingDate": "20131010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089776",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "ISONIAZID",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimycobacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20131010",
"SamplePackage": "N"
},
{
"NDCCode": "0527-1170-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0527-1170-01) ",
"NDC11Code": "00527-1170-01",
"ProductNDC": "0527-1170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
"NonProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19780221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085372",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE",
"StrengthNumber": ".025; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19780221",
"SamplePackage": "N",
"IndicationAndUsage": "Diphenoxylate HCl and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.",
"Description": "Each Diphenoxylate Hydrochloride and Atropine Sulfate Tablet, USP contains. 2.5 mg of diphenoxylate hydrochloride USP (equivalent to 2.3 mg of diphenoxylate) and 0.025 mg of atropine sulfate USP (equivalent to 0.01 mg of atropine). Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride and has the following structural formula. Atropine sulfate, an anticholinergic, is endo-(±)-α-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate and has the following structural formula. A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Inactive ingredients of diphenoxylate HCl and atropine sulfate tablets include lactose monohydrate, acacia, calcium stearate, methylcellulose, and cornstarch."
},
{
"NDCCode": "0527-1210-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0527-1210-01) ",
"NDC11Code": "00527-1210-01",
"ProductNDC": "0527-1210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neomycin Sulfate",
"NonProprietaryName": "Neomycin Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204435",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "NEOMYCIN SULFATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160610",
"SamplePackage": "N"
},
{
"NDCCode": "0527-1231-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0527-1231-01) ",
"NDC11Code": "00527-1231-01",
"ProductNDC": "0527-1231",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primidone",
"NonProprietaryName": "Primidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19781201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084903",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PRIMIDONE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-07-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19781201",
"SamplePackage": "N",
"IndicationAndUsage": "Primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.",
"Description": "Anticonvulsant. Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H,5H)-pyrimidinedione. Structural formula. Primidone is a white, crystalline, highly stable substance, M.P. 279 - 284°C. It is poorly soluble in water (60 mg per 100 mL at 37°C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog. Each tablet, for oral administration, contains either 50 mg or 250 mg of primidone. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, methylcellulose, acacia, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "0527-1282-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0527-1282-01) ",
"NDC11Code": "00527-1282-01",
"ProductNDC": "0527-1282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040230",
"LabelerName": "Lannett Company, LLC",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990226",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine Hydrochloride Capsules, USP for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, D&C Red No. 28, and FD&C Blue No. 1. , 2 Dicyclomine Hydrochloride Tablets, USP for oral use contain 20 mg dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: acacia, pregelatinized starch, anhydrous lactose, compressible sugar, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, stearic acid, and FD&C Blue No.1 Aluminum Lake."
},
{
"NDCCode": "0527-1301-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0527-1301-01) ",
"NDC11Code": "00527-1301-01",
"ProductNDC": "0527-1301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primidone",
"NonProprietaryName": "Primidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084903",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PRIMIDONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-07-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010524",
"SamplePackage": "N",
"IndicationAndUsage": "Primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.",
"Description": "Anticonvulsant. Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H,5H)-pyrimidinedione. Structural formula. Primidone is a white, crystalline, highly stable substance, M.P. 279 - 284°C. It is poorly soluble in water (60 mg per 100 mL at 37°C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog. Each tablet, for oral administration, contains either 50 mg or 250 mg of primidone. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, methylcellulose, acacia, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "0527-1308-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0527-1308-01) ",
"NDC11Code": "00527-1308-01",
"ProductNDC": "0527-1308",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087022",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20071201",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake."
},
{
"NDCCode": "0527-1310-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0527-1310-01) ",
"NDC11Code": "00527-1310-01",
"ProductNDC": "0527-1310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087022",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20071201",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake."
},
{
"NDCCode": "0527-1311-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0527-1311-01) ",
"NDC11Code": "00527-1311-01",
"ProductNDC": "0527-1311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terbutaline Sulfate",
"NonProprietaryName": "Terbutaline Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077152",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "TERBUTALINE SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-07-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050325",
"SamplePackage": "N",
"IndicationAndUsage": "Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.",
"Description": "Terbutaline sulfate USP is a beta-adrenergic agonist bronchodilator available as tablets of 2.5 mg (2.05 mg of the free base) and 5 mg (4.1 mg of the free base) for oral administration. Terbutaline sulfate is ±-α-[(tert –butylamino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). The molecular formula is (C12H19NO3)2 H2SO4 and the structural formula is. Terbutaline sulfate USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65. Inactive Ingredients: anhydrous lactose, pregelatinized corn starch, microcrystalline cellulose, povidone, and magnesium stearate."
},
{
"NDCCode": "0527-1312-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0527-1312-01) ",
"NDC11Code": "00527-1312-01",
"ProductNDC": "0527-1312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Aspirin, Caffeine And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Aspirin, Caffeine And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074951",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "325; 50; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19980831",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy of butalbital, aspirin, caffeine and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: 1) butalbital, aspirin, caffeine and codeine; 2) codeine; 3) butalbital, aspirin and caffeine; 4) placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. The combination product of butalbital, aspirin, caffeine and codeine proved statistically significantly superior to each of its components and to placebo on measures of pain relief. Evidence supporting the efficacy and safety of butalbital, aspirin, caffeine and codeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.",
"Description": "Each capsule for oral administration contains. codeine phosphate, USP . . . . . . . . . . . . 30 mg (1/2 gr)butalbital, USP . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mgcaffeine, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 mgaspirin, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . 325 mg. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is affected by light. Its chemical name is 7,8-didehydro-4,5α-epoxy-3-methoxy-17- methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Its molecular weight is 406.37 and its molecular formula is C18H21NO3H3PO4½H2O. Butalbital, 5-allyl-5-isobutyl-barbituric acid, a white odorless crystalline powder, is a short- to intermediate-acting barbiturate. Its molecular weight is 224.26 and its molecular formula is C11H16N2O3. Caffeine, 1,3,7-trimethylxanthine, is a central nervous stimulant which occurs as a white powder or white glistening needles. Its molecular weight is (anhydrous) 194.19 and its molecular formula is C8H10N4O2. Aspirin is benzoic acid, 2-(acetyloxy)-, with a molecular formula of C9H8O4 and its molecular weight is 180.16. Inactive Ingredients: D&C Yellow #10, D&C Yellow #10 Aluminum Lake, D&C Red #33, D&C Red #28, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Blue #10 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide, stearic acid, colloidal silicon dioxide."
},
{
"NDCCode": "0527-1313-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0527-1313-01) ",
"NDC11Code": "00527-1313-01",
"ProductNDC": "0527-1313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pilocarpine Hydrochloride",
"NonProprietaryName": "Pilocarpine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077220",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PILOCARPINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20051014",
"SamplePackage": "N",
"IndicationAndUsage": "Pilocarpine hydrochloride tablets, USP are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's syndrome.",
"Description": "Pilocarpine hydrochloride tablets, USP contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride, USP is a hygroscopic, odorless, bitter tasting white crystal or powder which is soluble in water and alcohol and virtually insoluble in most non-polar solvents. Pilocarpine hydrochloride, USP with a chemical name of (3S-cis)-2(3H)-Furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl]monohydrochloride, has a molecular weight of 244.72. Each 5 mg Pilocarpine Hydrochloride Tablet, USP for oral administration contains 5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet are microcrystalline cellulose and stearic acid, the tablet's film coating is: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Each 7.5 mg Pilocarpine Hydrochloride Tablet, USP for oral administration contains 7.5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet are microcrystalline cellulose and stearic acid, the tablet's film coating is: FD&C Blue #2/Indigo Carmine aluminum lake, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0527-1333-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0527-1333-01) </PackageDescription>
<NDC11Code>00527-1333-01</NDC11Code>
<ProductNDC>0527-1333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077241</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0115-1333-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1333-01)</PackageDescription>
<NDC11Code>00115-1333-01</NDC11Code>
<ProductNDC>0115-1333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131217</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021303</ApplicationNumber>
<LabelerName>Global Pharmaceuticals, Division of Impax Laboratories Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE</SubstanceName>
<StrengthNumber>7.5; 7.5; 7.5; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules (MAS-ER Capsules), a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). (1): 1 Children (ages 6-12): Efficacy was established in one 3-week outpatient, controlled trial and one analogue classroom, controlled trial in children with ADHD. (14) , 2 Adolescents (ages 13-17): Efficacy was established in one 4-week controlled trial in adolescents with ADHD. (14) , 3 Adults: Efficacy was established in one 4-week controlled trial in adults with ADHD. (14).</IndicationAndUsage>
<Description>MAS-ER Capsules are a once daily extended-release, single-entity amphetamine product. MAS-ER Capsules combine the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d,l-amphetamine aspartate monohydrate. The MAS-ER Capsules contain two types of drug-containing beads designed to give a double-pulsed delivery of amphetamines, which prolongs the release of amphetamine from MAS-ER Capsules compared to the conventional ADDERALL® (immediate-release) tablet formulation.</Description>
</NDC>
<NDC>
<NDCCode>0143-1333-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (0143-1333-01)</PackageDescription>
<NDC11Code>00143-1333-01</NDC11Code>
<ProductNDC>0143-1333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001005</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075361</ApplicationNumber>
<LabelerName>West-ward Pharmaceutical Corp</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0363-1333-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0363-1333-01) / 28 g in 1 TUBE</PackageDescription>
<NDC11Code>00363-1333-01</NDC11Code>
<ProductNDC>0363-1333</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250306</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Walgreens Co.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: 1 eczema, 2 insect bites, 3 poison ivy, 4 poison oak, 5 poison sumac, 6 soaps, 7 jewelry, 8 detergents, 9 cosmetics, 10 psoriasis, 11 seborrheic dermatitis, 12 for external genital, feminine and anal itching, 13 other uses of this product should be only under the advice and supervision of a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-1333-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-1333-1)</PackageDescription>
<NDC11Code>36987-1333-01</NDC11Code>
<ProductNDC>36987-1333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Grapefruit</ProprietaryName>
<NonProprietaryName>Grapefruit</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>GRAPEFRUIT</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],Fruit 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>37662-1333-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-1333-1) </PackageDescription>
<NDC11Code>37662-1333-01</NDC11Code>
<ProductNDC>37662-1333</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zincum Carbonicum</ProprietaryName>
<NonProprietaryName>Zincum Carbonicum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220812</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>ZINC CARBONATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43742-1333-1</NDCCode>
<PackageDescription>126 g in 1 BOTTLE, PUMP (43742-1333-1) </PackageDescription>
<NDC11Code>43742-1333-01</NDC11Code>
<ProductNDC>43742-1333</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trauma Relief</ProprietaryName>
<NonProprietaryName>Chamomilla, Echinacea (angustifolia), Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Calendula Officinalis, Arnica Montana, Belladonna, Bellis Perennis, Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos, Symphytum Officinale, Rhus Tox, Bryonia (alba), Hepar Sulphuris Calcareum, Carbo Vegetabilis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>MATRICARIA CHAMOMILLA WHOLE; ECHINACEA ANGUSTIFOLIA WHOLE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM WHOLE; ACHILLEA MILLEFOLIUM WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA WHOLE; ATROPA BELLADONNA; BELLIS PERENNIS WHOLE; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; COMFREY ROOT; TOXICODENDRON PUBESCENS LEAF; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ACTIVATED CHARCOAL</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 12</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of strains, sprains, and joint pain.**. **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>48951-1333-1</NDCCode>
<PackageDescription>10 AMPULE in 1 BOX (48951-1333-1) > 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>48951-1333-01</NDC11Code>
<ProductNDC>48951-1333</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica E Pl. Tota 10x Special Order</ProprietaryName>
<NonProprietaryName>Arnica E Pl. Tota 10x Special Order</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-1333-1</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (50090-1333-1) </PackageDescription>
<NDC11Code>50090-1333-01</NDC11Code>
<ProductNDC>50090-1333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
<NDC>
<NDCCode>51662-1333-1</NDCCode>
<PackageDescription>250 mL in 1 BAG (51662-1333-1) </PackageDescription>
<NDC11Code>51662-1333-01</NDC11Code>
<ProductNDC>51662-1333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Intralipid</ProprietaryName>
<NonProprietaryName>Intralipid</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181221</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018449</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>SOYBEAN OIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Lipid Emulsion [EPC], Lipids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Intralipid® 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source of essential fatty acids for prevention of EFAD.</IndicationAndUsage>
<Description>Intralipid® 20% (A 20% Intravenous Fat Emulsion) is a sterile, non-pyrogenic fat emulsion prepared for intravenous administration as a source of calories and essential fatty acids. It is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and Water for Injection. In addition, sodium hydroxide has been added to adjust the pH so that the final product pH is 8. pH range is 6 to 8.9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure. where. . . and. are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic acid (44-62%), oleic acid (19-30%), palmitic acid (7-14%), α-linolenic acid (4-11%) and stearic acid (1.4-5.5%).1 These fatty acids have the following chemical and structural formulas. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure. and. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula. Intralipid® 20% (A 20% Intravenous Fat Emulsion) has an osmolality of approximately 350 mOsmol/kg water (which represents 260 mOsmol/L of emulsion) and contains emulsified fat particles of approximately 0.5 micron size. The total caloric value, including fat, phospholipid and glycerin, is 2.0 kcal per mL of Intralipid® 20%. The phospholipids present contribute 47 milligrams or approximately 1.5 mmol of phosphorus per 100 mL of the emulsion. The primary plastic container (Biofine), is made from multilayered film specifically designed for parenteral nutrition drug products. The film is polypropylene based comprising three co-extruded layers. It contains no plasticizers and exhibits virtually no leachables. The container does not contain DEHP (di(2-ethylhexyl)phthalate) or PVC. The container is nontoxic and biologically inert. This product is not made with natural rubber latex. The container-emulsion unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.</Description>
</NDC>
<NDC>
<NDCCode>60505-1333-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (60505-1333-1)</PackageDescription>
<NDC11Code>60505-1333-01</NDC11Code>
<ProductNDC>60505-1333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077741</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-09-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67296-1333-1</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (67296-1333-1) </PackageDescription>
<NDC11Code>67296-1333-01</NDC11Code>
<ProductNDC>67296-1333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202991</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>325; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets, USP for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):. have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone bitartrate and acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. [hydrocodone structure]. C18H21NO3C4H6O62½H2O MW = 494.490. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. [acetaminophen structure]. C8H9NO2 MW = 151.16. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP, 5 mg/ 325 mg contains: Hydrocodone Bitartrate ………………....5 mg Acetaminophen ………………….…....325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP, 7.5 mg/ 325 mg contains: Hydrocodone Bitartrate ……………….7.5 mg Acetaminophen ……………………….325 mg. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP, 10 mg/ 325 mg contains: Hydrocodone Bitartrate …………….….10 mg Acetaminophen …………………….....325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch, crospovidone, magnesium stearate, povidone, and stearic acid. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>71335-1333-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71335-1333-1) </PackageDescription>
<NDC11Code>71335-1333-01</NDC11Code>
<ProductNDC>71335-1333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077210</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Monotherapy and Combination Therapy. Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)]. Important Limitations of Use. Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>Pioglitazone Tablets, USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. C19H20N2O3SHCl M.W. 392.90. Pioglitazone hydrochloride, USP is an odorless white crystalline powder. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets USP are available for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, and mannitol.</Description>
</NDC>
<NDC>
<NDCCode>0406-1333-05</NDCCode>
<PackageDescription>.5 kg in 1 BOTTLE (0406-1333-05) </PackageDescription>
<NDC11Code>00406-1333-05</NDC11Code>
<ProductNDC>0406-1333</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131120</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2024-08-29</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-NOV-13</StartMarketingDatePackage>
<EndMarketingDatePackage>01-MAR-31</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0406-1333-40</NDCCode>
<PackageDescription>.1 kg in 1 BOTTLE, GLASS (0406-1333-40) </PackageDescription>
<NDC11Code>00406-1333-40</NDC11Code>
<ProductNDC>0406-1333</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131120</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2025-01-02</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0406-1333-41</NDCCode>
<PackageDescription>5 kg in 1 PAIL (0406-1333-41) </PackageDescription>
<NDC11Code>00406-1333-41</NDC11Code>
<ProductNDC>0406-1333</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20131120</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2025-01-02</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0527-0586-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0527-0586-01) </PackageDescription>
<NDC11Code>00527-0586-01</NDC11Code>
<ProductNDC>0527-0586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19740930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084285</ApplicationNumber>
<LabelerName>Lannett Company, LLC</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine Hydrochloride Capsules, USP for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, D&C Red No. 28, and FD&C Blue No. 1. , 2 Dicyclomine Hydrochloride Tablets, USP for oral use contain 20 mg dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: acacia, pregelatinized starch, anhydrous lactose, compressible sugar, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, stearic acid, and FD&C Blue No.1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0527-0597-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0527-0597-01) </PackageDescription>
<NDC11Code>00527-0597-01</NDC11Code>
<ProductNDC>0527-0597</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087022</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0527-1050-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0527-1050-01) </PackageDescription>
<NDC11Code>00527-1050-01</NDC11Code>
<ProductNDC>0527-1050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetazolamide</ProprietaryName>
<NonProprietaryName>Acetazolamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19780331</StartMarketingDate>
<EndMarketingDate>20221031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084840</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>ACETAZOLAMIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19780331</StartMarketingDatePackage>
<EndMarketingDatePackage>20221031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0527-1109-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0527-1109-01) </PackageDescription>
<NDC11Code>00527-1109-01</NDC11Code>
<ProductNDC>0527-1109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isoniazid</ProprietaryName>
<NonProprietaryName>Isoniazid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL; ORAL</RouteName>
<StartMarketingDate>20131010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089776</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>ISONIAZID</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0527-1170-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0527-1170-01) </PackageDescription>
<NDC11Code>00527-1170-01</NDC11Code>
<ProductNDC>0527-1170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19780221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085372</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.025; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19780221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diphenoxylate HCl and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.</IndicationAndUsage>
<Description>Each Diphenoxylate Hydrochloride and Atropine Sulfate Tablet, USP contains. 2.5 mg of diphenoxylate hydrochloride USP (equivalent to 2.3 mg of diphenoxylate) and 0.025 mg of atropine sulfate USP (equivalent to 0.01 mg of atropine). Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride and has the following structural formula. Atropine sulfate, an anticholinergic, is endo-(±)-α-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate and has the following structural formula. A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Inactive ingredients of diphenoxylate HCl and atropine sulfate tablets include lactose monohydrate, acacia, calcium stearate, methylcellulose, and cornstarch.</Description>
</NDC>
<NDC>
<NDCCode>0527-1210-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0527-1210-01) </PackageDescription>
<NDC11Code>00527-1210-01</NDC11Code>
<ProductNDC>0527-1210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neomycin Sulfate</ProprietaryName>
<NonProprietaryName>Neomycin Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204435</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>NEOMYCIN SULFATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0527-1231-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0527-1231-01) </PackageDescription>
<NDC11Code>00527-1231-01</NDC11Code>
<ProductNDC>0527-1231</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Primidone</ProprietaryName>
<NonProprietaryName>Primidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19781201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084903</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PRIMIDONE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19781201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.</IndicationAndUsage>
<Description>Anticonvulsant. Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H,5H)-pyrimidinedione. Structural formula. Primidone is a white, crystalline, highly stable substance, M.P. 279 - 284°C. It is poorly soluble in water (60 mg per 100 mL at 37°C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog. Each tablet, for oral administration, contains either 50 mg or 250 mg of primidone. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, methylcellulose, acacia, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0527-1282-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0527-1282-01) </PackageDescription>
<NDC11Code>00527-1282-01</NDC11Code>
<ProductNDC>0527-1282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040230</ApplicationNumber>
<LabelerName>Lannett Company, LLC</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine Hydrochloride Capsules, USP for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, D&C Red No. 28, and FD&C Blue No. 1. , 2 Dicyclomine Hydrochloride Tablets, USP for oral use contain 20 mg dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: acacia, pregelatinized starch, anhydrous lactose, compressible sugar, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, stearic acid, and FD&C Blue No.1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0527-1301-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0527-1301-01) </PackageDescription>
<NDC11Code>00527-1301-01</NDC11Code>
<ProductNDC>0527-1301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Primidone</ProprietaryName>
<NonProprietaryName>Primidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084903</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PRIMIDONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.</IndicationAndUsage>
<Description>Anticonvulsant. Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H,5H)-pyrimidinedione. Structural formula. Primidone is a white, crystalline, highly stable substance, M.P. 279 - 284°C. It is poorly soluble in water (60 mg per 100 mL at 37°C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog. Each tablet, for oral administration, contains either 50 mg or 250 mg of primidone. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, methylcellulose, acacia, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0527-1308-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0527-1308-01) </PackageDescription>
<NDC11Code>00527-1308-01</NDC11Code>
<ProductNDC>0527-1308</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087022</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0527-1310-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0527-1310-01) </PackageDescription>
<NDC11Code>00527-1310-01</NDC11Code>
<ProductNDC>0527-1310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087022</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine Hydrochloride Capsule, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0527-1311-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0527-1311-01) </PackageDescription>
<NDC11Code>00527-1311-01</NDC11Code>
<ProductNDC>0527-1311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terbutaline Sulfate</ProprietaryName>
<NonProprietaryName>Terbutaline Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050325</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077152</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>TERBUTALINE SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.</IndicationAndUsage>
<Description>Terbutaline sulfate USP is a beta-adrenergic agonist bronchodilator available as tablets of 2.5 mg (2.05 mg of the free base) and 5 mg (4.1 mg of the free base) for oral administration. Terbutaline sulfate is ±-α-[(tert –butylamino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). The molecular formula is (C12H19NO3)2 H2SO4 and the structural formula is. Terbutaline sulfate USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65. Inactive Ingredients: anhydrous lactose, pregelatinized corn starch, microcrystalline cellulose, povidone, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0527-1312-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0527-1312-01) </PackageDescription>
<NDC11Code>00527-1312-01</NDC11Code>
<ProductNDC>0527-1312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Aspirin, Caffeine And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin, Caffeine And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074951</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>325; 50; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy of butalbital, aspirin, caffeine and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: 1) butalbital, aspirin, caffeine and codeine; 2) codeine; 3) butalbital, aspirin and caffeine; 4) placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. The combination product of butalbital, aspirin, caffeine and codeine proved statistically significantly superior to each of its components and to placebo on measures of pain relief. Evidence supporting the efficacy and safety of butalbital, aspirin, caffeine and codeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Each capsule for oral administration contains. codeine phosphate, USP . . . . . . . . . . . . 30 mg (1/2 gr)butalbital, USP . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mgcaffeine, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 mgaspirin, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . 325 mg. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is affected by light. Its chemical name is 7,8-didehydro-4,5α-epoxy-3-methoxy-17- methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Its molecular weight is 406.37 and its molecular formula is C18H21NO3H3PO4½H2O. Butalbital, 5-allyl-5-isobutyl-barbituric acid, a white odorless crystalline powder, is a short- to intermediate-acting barbiturate. Its molecular weight is 224.26 and its molecular formula is C11H16N2O3. Caffeine, 1,3,7-trimethylxanthine, is a central nervous stimulant which occurs as a white powder or white glistening needles. Its molecular weight is (anhydrous) 194.19 and its molecular formula is C8H10N4O2. Aspirin is benzoic acid, 2-(acetyloxy)-, with a molecular formula of C9H8O4 and its molecular weight is 180.16. Inactive Ingredients: D&C Yellow #10, D&C Yellow #10 Aluminum Lake, D&C Red #33, D&C Red #28, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Blue #10 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide, stearic acid, colloidal silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0527-1313-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0527-1313-01) </PackageDescription>
<NDC11Code>00527-1313-01</NDC11Code>
<ProductNDC>0527-1313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pilocarpine Hydrochloride</ProprietaryName>
<NonProprietaryName>Pilocarpine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077220</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PILOCARPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pilocarpine hydrochloride tablets, USP are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's syndrome.</IndicationAndUsage>
<Description>Pilocarpine hydrochloride tablets, USP contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride, USP is a hygroscopic, odorless, bitter tasting white crystal or powder which is soluble in water and alcohol and virtually insoluble in most non-polar solvents. Pilocarpine hydrochloride, USP with a chemical name of (3S-cis)-2(3H)-Furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl]monohydrochloride, has a molecular weight of 244.72. Each 5 mg Pilocarpine Hydrochloride Tablet, USP for oral administration contains 5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet are microcrystalline cellulose and stearic acid, the tablet's film coating is: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Each 7.5 mg Pilocarpine Hydrochloride Tablet, USP for oral administration contains 7.5 mg of pilocarpine hydrochloride. Inactive ingredients in the tablet are microcrystalline cellulose and stearic acid, the tablet's film coating is: FD&C Blue #2/Indigo Carmine aluminum lake, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc.</Description>
</NDC>
</NDCList>