{
"NDC": [
{
"NDCCode": "66096-169-03",
"PackageDescription": "50 g in 1 TUBE (66096-169-03) ",
"NDC11Code": "66096-0169-03",
"ProductNDC": "66096-169",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Acne Relief",
"NonProprietaryName": "Calendula Officinalis, Chamomilla, Hamamelis Virginiana, Hepar Sulphuris Calcareum, Sulphur.",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160222",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA CHAMOMILLA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; SULFUR",
"StrengthNumber": "1; 1; 2; 6; 6",
"StrengthUnit": "[hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20160222",
"SamplePackage": "N"
},
{
"NDCCode": "66096-747-03",
"PackageDescription": "50 g in 1 TUBE (66096-747-03) ",
"NDC11Code": "66096-0747-03",
"ProductNDC": "66096-747",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acne Relief Gel",
"NonProprietaryName": "Calendula Officinalis, Chamomilla, Berberis Aquafolium, Hamamelis, Hepar Sulph. Calc. , Sulphur",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA CHAMOMILLA; BERBERIS AQUIFOLIUM ROOT BARK; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; SULFUR",
"StrengthNumber": "1; 1; 2; 2; 6; 6",
"StrengthUnit": "[hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g",
"Status": "Active",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181129",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves pimples, blemishes, redness and swelling due to simple acne. Promotes natural skin healing.**."
},
{
"NDCCode": "11534-169-03",
"PackageDescription": "1000 TABLET in 1 BOTTLE (11534-169-03)",
"NDC11Code": "11534-0169-03",
"ProductNDC": "11534-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204713",
"LabelerName": "SUNRISE PHARMACEUTICAL, INC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-12-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "29300-169-03",
"PackageDescription": "300 TABLET in 1 BOTTLE, PLASTIC (29300-169-03) ",
"NDC11Code": "29300-0169-03",
"ProductNDC": "29300-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091283",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130401",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. (1).",
"Description": "Tizanidine Tablets contains tizanidine hydrochloride as the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3- benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Tizanidine tablets, are for oral administration and contain 2 or 4 mg tizanidine (equivalent to 2.288 mg and 4.576 mg tizanidine hydrochloride, respectively), and the inactive ingredients anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose, and stearic acid."
},
{
"NDCCode": "49944-010-03",
"PackageDescription": "169 L in 1 CYLINDER (49944-010-03) ",
"NDC11Code": "49944-0010-03",
"ProductNDC": "49944-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19830101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "I.D.M. Medical Supply Company Inc.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830101",
"SamplePackage": "N"
},
{
"NDCCode": "54340-169-03",
"PackageDescription": "221 mL in 1 BOTTLE, DISPENSING (54340-169-03) ",
"NDC11Code": "54340-0169-03",
"ProductNDC": "54340-169",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dial Complete Limited Edition Fhw Ice Crystals",
"NonProprietaryName": "Dial Complete Limited Edition Fhw Ice Crystals",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Henkel Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Kills 99.99% bacteria. For handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "63545-169-03",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (63545-169-03) ",
"NDC11Code": "63545-0169-03",
"ProductNDC": "63545-169",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arsenicum Album",
"NonProprietaryName": "Arsenicum Album",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210323",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "ARSENIC TRIOXIDE",
"StrengthNumber": "12",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2021-03-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210323",
"SamplePackage": "N"
},
{
"NDCCode": "64220-169-03",
"PackageDescription": "15 kg in 1 CANISTER (64220-169-03)",
"NDC11Code": "64220-0169-03",
"ProductNDC": "64220-169",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170322",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CV",
"Status": "Unfinished",
"LastUpdate": "2020-01-03",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "68726-169-03",
"PackageDescription": "1 TUBE in 1 CARTON (68726-169-03) > 7 g in 1 TUBE (68726-169-02)",
"NDC11Code": "68726-0169-03",
"ProductNDC": "68726-169",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pca Skin Acne",
"NonProprietaryName": "Benzoyl Perozide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Physicians Care Alliance DBA PCA SKIN",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "69241-001-03",
"PackageDescription": "169 L in 1 CYLINDER (69241-001-03) ",
"NDC11Code": "69241-0001-03",
"ProductNDC": "69241-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205849",
"LabelerName": "RTA Pediatric Care Inc.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Active",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N"
},
{
"NDCCode": "69339-169-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (69339-169-03) ",
"NDC11Code": "69339-0169-03",
"ProductNDC": "69339-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209555",
"LabelerName": "Natco Pharma USA LLC",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "7",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240102",
"SamplePackage": "N",
"IndicationAndUsage": "Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water.Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The film coating for the 14 mg tablet is made of FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. In addition to these, the 7 mg tablet film coating includes iron oxide yellow."
},
{
"NDCCode": "70436-169-03",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70436-169-03) ",
"NDC11Code": "70436-0169-03",
"ProductNDC": "70436-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibric Acid",
"NonProprietaryName": "Fenofibric Acid",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212562",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "FENOFIBRIC ACID",
"StrengthNumber": "135",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220411",
"SamplePackage": "N",
"Description": "Fenofibric Acid Delayed-Release Capsules are a lipid regulating agent available as delayed-release capsules for oral administration. Each delayed-release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2hydroxy-N,N,N-trimethyl, 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate (1:1) with the following structural formula. The empirical formula is C 22H 28ClNO 5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water. The melting point is approximately 210°C. Choline fenofibrate is a white to yellow powder, which is stable under ordinary conditions. Each delayed-release capsule contains enteric coated pellets comprised of choline fenofibrate and the following inactive ingredients: ethylcellulose, hypromellose, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, povidone, sodium chloride, sodium lauryl sulfate, sugar spheres, talc, and triethyl citrate. The capsule shell contains FD&C blue no. 1 (135 mg), ferric oxide red (45 mg), ferric oxide yellow, gelatin, and titanium dioxide. The capsules are printed with black ink containing ferrosoferric oxide, potassium hydroxide, and shellac."
},
{
"NDCCode": "72973-001-03",
"PackageDescription": "169.9 L in 1 CYLINDER (72973-001-03) ",
"NDC11Code": "72973-0001-03",
"ProductNDC": "72973-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20190318",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205849",
"LabelerName": "HOWARDS MEDICAL LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190318",
"SamplePackage": "N"
},
{
"NDCCode": "83589-169-03",
"PackageDescription": "5 g in 1 BOTTLE (83589-169-03) ",
"NDC11Code": "83589-0169-03",
"ProductNDC": "83589-169",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Selank Diacetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Nanjing Chengong Pharmaceutical Co., Ltd.",
"SubstanceName": "SELANK DIACETATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "01-MAY-26"
},
{
"NDCCode": "66096-011-32",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-011-32) ",
"NDC11Code": "66096-0011-32",
"ProductNDC": "66096-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anx-ohm",
"NonProprietaryName": "Argentum Nitricum, Avena Sativa, Aurum Metallicum, Gelsemium, Hyosciamus Niger, Ignatia, Moschus, Natrum Muriaticum, Passiflora Incarnata, Stannum Metallicum, Valeriana Officinalis",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "SILVER NITRATE; AVENA SATIVA FLOWERING TOP; GOLD; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS WHOLE; SODIUM CHLORIDE; PASSIFLORA INCARNATA TOP; TIN; VALERIAN",
"StrengthNumber": "14; 5; 14; 14; 14; 14; 14; 14; 5; 16; 5",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100101",
"SamplePackage": "N"
},
{
"NDCCode": "66096-174-06",
"PackageDescription": "12 AMPULE in 1 BOX (66096-174-06) > 2.2 mL in 1 AMPULE",
"NDC11Code": "66096-0174-06",
"ProductNDC": "66096-174",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Digestive Terrain",
"NonProprietaryName": "Bryonia Alba, China Officinalis, Hydrastis Canadensis, Kali Bichromicum, Lycopodium Clavatum, Nux Moschata, Nux Vomica, Thuja Occidentalis.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110525",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; NUTMEG; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "7; 5; 7; 8; 8; 6; 7; 9",
"StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110525",
"SamplePackage": "N"
},
{
"NDCCode": "66096-175-06",
"PackageDescription": "12 AMPULE in 1 BOX (66096-175-06) > 2.2 mL in 1 AMPULE",
"NDC11Code": "66096-0175-06",
"ProductNDC": "66096-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Endocrine Feminine Terrain",
"NonProprietaryName": "Cyclamen Europaeum, Erigeron Canadensis, Ignatia Amara, Lachesis Mutus, Moschus, Oophorinum, Pulsatilla, Sepia, Thlaspi Bursa-pastoris, Viburnum Opulus.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120312",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "CYCLAMEN PURPURASCENS TUBER; CONYZA CANADENSIS; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MOSCHUS MOSCHIFERUS WHOLE; SUS SCROFA OVARY; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; CAPSELLA BURSA-PASTORIS; VIBURNUM OPULUS BARK",
"StrengthNumber": "7; 6; 12; 12; 12; 8; 12; 12; 6; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120312",
"SamplePackage": "N"
},
{
"NDCCode": "66096-179-06",
"PackageDescription": "12 AMPULE in 1 BOX (66096-179-06) > 2.2 mL in 1 AMPULE",
"NDC11Code": "66096-0179-06",
"ProductNDC": "66096-179",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Circulatory Terrain",
"NonProprietaryName": "Baryta Iodata, Cactus Grandiflorus, Carbo Vegetabilis, Crataegus Oxyacantha, Curare, Kali Carbonicum, Kalmia Latifolia, Melilotus Officinale, Naja Tripudians, Secale Cornutum, Solanum Nigrum, Spigelia Anthelmia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150423",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "BARIUM IODIDE; SELENICEREUS GRANDIFLORUS STEM; ACTIVATED CHARCOAL; HAWTHORN LEAF WITH FLOWER; TUBOCURARINE CHLORIDE; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; MELILOTUS OFFICINALIS TOP; NAJA NAJA VENOM; CLAVICEPS PURPUREA SCLEROTIUM; SOLANUM NIGRUM TOP; SPIGELIA ANTHELMIA",
"StrengthNumber": "12; 6; 12; 6; 12; 7; 6; 6; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150423",
"SamplePackage": "N"
},
{
"NDCCode": "66096-184-06",
"PackageDescription": "12 AMPULE in 1 BOX (66096-184-06) > 2.2 mL in 1 AMPULE",
"NDC11Code": "66096-0184-06",
"ProductNDC": "66096-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Dermatological Terrain",
"NonProprietaryName": "Calcarea Carbonica, Calcarea Fluorica, Carduus Marianus, China Officinalis, Cynara Scolymus, Galium Aparine, Graphites, Hepar Sulphuris Calcareum, Manganum Phosphoricum, Nicotinamidum, Oleander, Taraxacum Officinale, Thuja Occidentalis.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150413",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; MILK THISTLE; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; GALIUM APARINE; GRAPHITE; CALCIUM SULFIDE; MANGANESE PHOSPHATE, DIBASIC; NIACINAMIDE; NERIUM OLEANDER LEAF; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "12; 12; 5; 5; 8; 8; 12; 12; 8; 7; 6; 6; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150413",
"SamplePackage": "N"
},
{
"NDCCode": "66096-671-05",
"PackageDescription": "59 mL in 1 BOTTLE, GLASS (66096-671-05) ",
"NDC11Code": "66096-0671-05",
"ProductNDC": "66096-671",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ohm Allergy Grass, Weed, Tree Mix",
"NonProprietaryName": "Bermuda, Birch Mix, Brome, Carduus Marianus, Chelidonium Majus, Common Mugwort, English Plantain, Goldenrod, Hydrastis Canadensis, Histam, Johnson, Kentucky, Maple Mix, Nasturtium Aqua, Oak Mix, Orchard, Pigweed Mix, Pine Mix, Ragweed Mix, Red Cedar, Red Mulb, Scrophularia Nod, Sheep Sorrel, Soildago Virg, Sweet Vernal, Taraxacum Offi, Timothy, White Poplar.",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130313",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ACER PSEUDOPLATANUS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA VULGARIS POLLEN; BETULA PENDULA WHOLE; BROMUS SECALINUS TOP; CHELIDONIUM MAJUS; CYNODON DACTYLON; DACTYLIS GLOMERATA POLLEN; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA POLLEN; MILK THISTLE; MORUS RUBRA POLLEN; NASTURTIUM OFFICINALE; PHLEUM PRATENSE POLLEN; PINUS MASSONIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; QUERCUS SPP. WHOLE; RUMEX ACETOSELLA POLLEN; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; SOLIDAGO VIRGAUREA POLLEN; SORGHUM HALEPENSE POLLEN; TARAXACUM OFFICINALE POLLEN",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 3; 6; 6; 5; 60; 6; 3; 6; 3; 6; 6; 6; 6; 6; 6; 6; 3; 3; 6; 6; 3",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130313",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves sneezing, runny nose, itchy eyes and congestion associated with exposure to grasses, weeds and trees. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica."
},
{
"NDCCode": "66096-753-02",
"PackageDescription": "30 mL in 1 PACKAGE (66096-753-02) ",
"NDC11Code": "66096-0753-02",
"ProductNDC": "66096-753",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ohm-cir",
"NonProprietaryName": "Baryta Iodata, Cactus Grandiflorus, Carbo Vegetabilis, Crataegus Oxyacantha, Curare, Kali Carbonicum, Kalmia Latifolia, Melilotus Officinale, Naja Tripudians, Secale Cornutum, Solanum Nigrum, Spigelia Anthelmia",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20181219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "BARIUM IODIDE; SELENICEREUS GRANDIFLORUS STEM; ACTIVATED CHARCOAL; HAWTHORN LEAF WITH FLOWER; TUBOCURARINE CHLORIDE; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; MELILOTUS OFFICINALIS TOP; NAJA NAJA VENOM; CLAVICEPS PURPUREA SCLEROTIUM; SOLANUM NIGRUM TOP; SPIGELIA ANTHELMIA",
"StrengthNumber": "12; 6; 12; 6; 12; 7; 6; 6; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Active",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181219",
"SamplePackage": "N",
"IndicationAndUsage": "Contraindicaciones: Ninguna reportada."
},
{
"NDCCode": "66096-757-02",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-757-02) ",
"NDC11Code": "66096-0757-02",
"ProductNDC": "66096-757",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ohm-inma",
"NonProprietaryName": "Aconitum Napellus, Aranea Diadema, Arnica Montana, Asclepias Vincetoxicum, Baptisia Tinctoria, Bryonia Alba, Echinacea Angustifolia, Equisetum Hyemale, Eupatorium Perforliatum, Gelsemium Sempervirens, Hepar Sulphuris Calcareum, Juglans Regia, Phytolacca Decandra, Sanguinaria Canadensis, Sarsaparilla, Sulphur, Zincum Metallicum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20181219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ACONITUM NAPELLUS; ARANEUS DIADEMATUS; ARNICA MONTANA; CYNANCHUM VINCETOXICUM ROOT; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; EQUISETUM HYEMALE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; JUGLANS REGIA LEAF; PHYTOLACCA AMERICANA ROOT; SANGUINARIA CANADENSIS ROOT; SARSAPARILLA; SULFUR; ZINC",
"StrengthNumber": "7; 9; 6; 12; 8; 10; 6; 7; 10; 8; 12; 6; 10; 8; 9; 10; 12",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Status": "Active",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181219",
"SamplePackage": "N",
"IndicationAndUsage": "Contraindicaciones: Ninguna reportada."
},
{
"NDCCode": "66096-758-02",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (66096-758-02) ",
"NDC11Code": "66096-0758-02",
"ProductNDC": "66096-758",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ohm-ost",
"NonProprietaryName": "Arnica Montana, Calcarea Phosphorica, Causticum, China Officinalis, Colchicum Autumnale, Dulcamara, Ledum Palustre, Rhus Toxicodendron, Symphytum Officinale",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20181219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "OHM PHARMA INC.",
"SubstanceName": "ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF; COMFREY ROOT",
"StrengthNumber": "4; 12; 12; 12; 12; 6; 7; 12; 8",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2021-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181219",
"SamplePackage": "N",
"IndicationAndUsage": "Contraindicaciones: Ninguna reportada."
},
{
"NDCCode": "0074-2108-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-2108-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-2108-03",
"ProductNDC": "0074-2108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19930416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930416",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-2282-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-2282-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-2282-03",
"ProductNDC": "0074-2282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19930416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930416",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-2440-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-2440-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-2440-03",
"ProductNDC": "0074-2440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19930416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930416",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3346-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-3346-03) * 1.5 mL in 1 SYRINGE (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3346-03",
"ProductNDC": "0074-3346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19951222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020517",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951223",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3473-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-3473-03) * 1.5 mL in 1 SYRINGE (0074-9945-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3473-03",
"ProductNDC": "0074-3473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19951222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020517",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951223",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3642-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-3642-03) * 1 mL in 1 SYRINGE (0074-9907-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3642-03",
"ProductNDC": "0074-3642",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19890126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019732",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19890127",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3683-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-3683-03) * 1.5 mL in 1 SYRINGE (0074-9930-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3683-03",
"ProductNDC": "0074-3683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19951222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020517",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951223",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
}
]
}
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<NDC>
<NDCCode>66096-169-03</NDCCode>
<PackageDescription>50 g in 1 TUBE (66096-169-03) </PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Calendula Officinalis, Chamomilla, Hamamelis Virginiana, Hepar Sulphuris Calcareum, Sulphur.</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA CHAMOMILLA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; SULFUR</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-747-03</NDCCode>
<PackageDescription>50 g in 1 TUBE (66096-747-03) </PackageDescription>
<NDC11Code>66096-0747-03</NDC11Code>
<ProductNDC>66096-747</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acne Relief Gel</ProprietaryName>
<NonProprietaryName>Calendula Officinalis, Chamomilla, Berberis Aquafolium, Hamamelis, Hepar Sulph. Calc. , Sulphur</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
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<StartMarketingDate>20181129</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA CHAMOMILLA; BERBERIS AQUIFOLIUM ROOT BARK; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; SULFUR</SubstanceName>
<StrengthNumber>1; 1; 2; 2; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181129</StartMarketingDatePackage>
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<IndicationAndUsage>USES: Temporarily relieves pimples, blemishes, redness and swelling due to simple acne. Promotes natural skin healing.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11534-169-03</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (11534-169-03)</PackageDescription>
<NDC11Code>11534-0169-03</NDC11Code>
<ProductNDC>11534-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204713</ApplicationNumber>
<LabelerName>SUNRISE PHARMACEUTICAL, INC</LabelerName>
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<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>29300-169-03</NDCCode>
<PackageDescription>300 TABLET in 1 BOTTLE, PLASTIC (29300-169-03) </PackageDescription>
<NDC11Code>29300-0169-03</NDC11Code>
<ProductNDC>29300-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091283</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. (1).</IndicationAndUsage>
<Description>Tizanidine Tablets contains tizanidine hydrochloride as the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3- benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Tizanidine tablets, are for oral administration and contain 2 or 4 mg tizanidine (equivalent to 2.288 mg and 4.576 mg tizanidine hydrochloride, respectively), and the inactive ingredients anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>49944-010-03</NDCCode>
<PackageDescription>169 L in 1 CYLINDER (49944-010-03) </PackageDescription>
<NDC11Code>49944-0010-03</NDC11Code>
<ProductNDC>49944-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19830101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>I.D.M. Medical Supply Company Inc.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54340-169-03</NDCCode>
<PackageDescription>221 mL in 1 BOTTLE, DISPENSING (54340-169-03) </PackageDescription>
<NDC11Code>54340-0169-03</NDC11Code>
<ProductNDC>54340-169</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dial Complete Limited Edition Fhw Ice Crystals</ProprietaryName>
<NonProprietaryName>Dial Complete Limited Edition Fhw Ice Crystals</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Henkel Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Kills 99.99% bacteria. For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63545-169-03</NDCCode>
<PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (63545-169-03) </PackageDescription>
<NDC11Code>63545-0169-03</NDC11Code>
<ProductNDC>63545-169</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arsenicum Album</ProprietaryName>
<NonProprietaryName>Arsenicum Album</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210323</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-03-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64220-169-03</NDCCode>
<PackageDescription>15 kg in 1 CANISTER (64220-169-03)</PackageDescription>
<NDC11Code>64220-0169-03</NDC11Code>
<ProductNDC>64220-169</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170322</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2020-01-03</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68726-169-03</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68726-169-03) > 7 g in 1 TUBE (68726-169-02)</PackageDescription>
<NDC11Code>68726-0169-03</NDC11Code>
<ProductNDC>68726-169</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pca Skin Acne</ProprietaryName>
<NonProprietaryName>Benzoyl Perozide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Physicians Care Alliance DBA PCA SKIN</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>69241-001-03</NDCCode>
<PackageDescription>169 L in 1 CYLINDER (69241-001-03) </PackageDescription>
<NDC11Code>69241-0001-03</NDC11Code>
<ProductNDC>69241-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205849</ApplicationNumber>
<LabelerName>RTA Pediatric Care Inc.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69339-169-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69339-169-03) </PackageDescription>
<NDC11Code>69339-0169-03</NDC11Code>
<ProductNDC>69339-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriflunomide</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209555</ApplicationNumber>
<LabelerName>Natco Pharma USA LLC</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water.Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The film coating for the 14 mg tablet is made of FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>70436-169-03</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70436-169-03) </PackageDescription>
<NDC11Code>70436-0169-03</NDC11Code>
<ProductNDC>70436-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibric Acid</ProprietaryName>
<NonProprietaryName>Fenofibric Acid</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212562</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FENOFIBRIC ACID</SubstanceName>
<StrengthNumber>135</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Fenofibric Acid Delayed-Release Capsules are a lipid regulating agent available as delayed-release capsules for oral administration. Each delayed-release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2hydroxy-N,N,N-trimethyl, 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate (1:1) with the following structural formula. The empirical formula is C 22H 28ClNO 5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water. The melting point is approximately 210°C. Choline fenofibrate is a white to yellow powder, which is stable under ordinary conditions. Each delayed-release capsule contains enteric coated pellets comprised of choline fenofibrate and the following inactive ingredients: ethylcellulose, hypromellose, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, povidone, sodium chloride, sodium lauryl sulfate, sugar spheres, talc, and triethyl citrate. The capsule shell contains FD&C blue no. 1 (135 mg), ferric oxide red (45 mg), ferric oxide yellow, gelatin, and titanium dioxide. The capsules are printed with black ink containing ferrosoferric oxide, potassium hydroxide, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72973-001-03</NDCCode>
<PackageDescription>169.9 L in 1 CYLINDER (72973-001-03) </PackageDescription>
<NDC11Code>72973-0001-03</NDC11Code>
<ProductNDC>72973-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20190318</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205849</ApplicationNumber>
<LabelerName>HOWARDS MEDICAL LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83589-169-03</NDCCode>
<PackageDescription>5 g in 1 BOTTLE (83589-169-03) </PackageDescription>
<NDC11Code>83589-0169-03</NDC11Code>
<ProductNDC>83589-169</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Selank Diacetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Nanjing Chengong Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>SELANK DIACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-MAY-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>66096-011-32</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-011-32) </PackageDescription>
<NDC11Code>66096-0011-32</NDC11Code>
<ProductNDC>66096-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anx-ohm</ProprietaryName>
<NonProprietaryName>Argentum Nitricum, Avena Sativa, Aurum Metallicum, Gelsemium, Hyosciamus Niger, Ignatia, Moschus, Natrum Muriaticum, Passiflora Incarnata, Stannum Metallicum, Valeriana Officinalis</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>SILVER NITRATE; AVENA SATIVA FLOWERING TOP; GOLD; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS WHOLE; SODIUM CHLORIDE; PASSIFLORA INCARNATA TOP; TIN; VALERIAN</SubstanceName>
<StrengthNumber>14; 5; 14; 14; 14; 14; 14; 14; 5; 16; 5</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-174-06</NDCCode>
<PackageDescription>12 AMPULE in 1 BOX (66096-174-06) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>66096-0174-06</NDC11Code>
<ProductNDC>66096-174</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Digestive Terrain</ProprietaryName>
<NonProprietaryName>Bryonia Alba, China Officinalis, Hydrastis Canadensis, Kali Bichromicum, Lycopodium Clavatum, Nux Moschata, Nux Vomica, Thuja Occidentalis.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110525</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; NUTMEG; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>7; 5; 7; 8; 8; 6; 7; 9</StrengthNumber>
<StrengthUnit>[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-175-06</NDCCode>
<PackageDescription>12 AMPULE in 1 BOX (66096-175-06) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>66096-0175-06</NDC11Code>
<ProductNDC>66096-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Endocrine Feminine Terrain</ProprietaryName>
<NonProprietaryName>Cyclamen Europaeum, Erigeron Canadensis, Ignatia Amara, Lachesis Mutus, Moschus, Oophorinum, Pulsatilla, Sepia, Thlaspi Bursa-pastoris, Viburnum Opulus.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120312</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>CYCLAMEN PURPURASCENS TUBER; CONYZA CANADENSIS; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MOSCHUS MOSCHIFERUS WHOLE; SUS SCROFA OVARY; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; CAPSELLA BURSA-PASTORIS; VIBURNUM OPULUS BARK</SubstanceName>
<StrengthNumber>7; 6; 12; 12; 12; 8; 12; 12; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-179-06</NDCCode>
<PackageDescription>12 AMPULE in 1 BOX (66096-179-06) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>66096-0179-06</NDC11Code>
<ProductNDC>66096-179</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Circulatory Terrain</ProprietaryName>
<NonProprietaryName>Baryta Iodata, Cactus Grandiflorus, Carbo Vegetabilis, Crataegus Oxyacantha, Curare, Kali Carbonicum, Kalmia Latifolia, Melilotus Officinale, Naja Tripudians, Secale Cornutum, Solanum Nigrum, Spigelia Anthelmia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150423</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>BARIUM IODIDE; SELENICEREUS GRANDIFLORUS STEM; ACTIVATED CHARCOAL; HAWTHORN LEAF WITH FLOWER; TUBOCURARINE CHLORIDE; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; MELILOTUS OFFICINALIS TOP; NAJA NAJA VENOM; CLAVICEPS PURPUREA SCLEROTIUM; SOLANUM NIGRUM TOP; SPIGELIA ANTHELMIA</SubstanceName>
<StrengthNumber>12; 6; 12; 6; 12; 7; 6; 6; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-184-06</NDCCode>
<PackageDescription>12 AMPULE in 1 BOX (66096-184-06) > 2.2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>66096-0184-06</NDC11Code>
<ProductNDC>66096-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Dermatological Terrain</ProprietaryName>
<NonProprietaryName>Calcarea Carbonica, Calcarea Fluorica, Carduus Marianus, China Officinalis, Cynara Scolymus, Galium Aparine, Graphites, Hepar Sulphuris Calcareum, Manganum Phosphoricum, Nicotinamidum, Oleander, Taraxacum Officinale, Thuja Occidentalis.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150413</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; MILK THISTLE; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; GALIUM APARINE; GRAPHITE; CALCIUM SULFIDE; MANGANESE PHOSPHATE, DIBASIC; NIACINAMIDE; NERIUM OLEANDER LEAF; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>12; 12; 5; 5; 8; 8; 12; 12; 8; 7; 6; 6; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66096-671-05</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, GLASS (66096-671-05) </PackageDescription>
<NDC11Code>66096-0671-05</NDC11Code>
<ProductNDC>66096-671</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ohm Allergy Grass, Weed, Tree Mix</ProprietaryName>
<NonProprietaryName>Bermuda, Birch Mix, Brome, Carduus Marianus, Chelidonium Majus, Common Mugwort, English Plantain, Goldenrod, Hydrastis Canadensis, Histam, Johnson, Kentucky, Maple Mix, Nasturtium Aqua, Oak Mix, Orchard, Pigweed Mix, Pine Mix, Ragweed Mix, Red Cedar, Red Mulb, Scrophularia Nod, Sheep Sorrel, Soildago Virg, Sweet Vernal, Taraxacum Offi, Timothy, White Poplar.</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130313</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ACER PSEUDOPLATANUS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA VULGARIS POLLEN; BETULA PENDULA WHOLE; BROMUS SECALINUS TOP; CHELIDONIUM MAJUS; CYNODON DACTYLON; DACTYLIS GLOMERATA POLLEN; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA POLLEN; MILK THISTLE; MORUS RUBRA POLLEN; NASTURTIUM OFFICINALE; PHLEUM PRATENSE POLLEN; PINUS MASSONIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; QUERCUS SPP. WHOLE; RUMEX ACETOSELLA POLLEN; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; SOLIDAGO VIRGAUREA POLLEN; SORGHUM HALEPENSE POLLEN; TARAXACUM OFFICINALE POLLEN</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 3; 6; 6; 5; 60; 6; 3; 6; 3; 6; 6; 6; 6; 6; 6; 6; 3; 3; 6; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves sneezing, runny nose, itchy eyes and congestion associated with exposure to grasses, weeds and trees. **This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-753-02</NDCCode>
<PackageDescription>30 mL in 1 PACKAGE (66096-753-02) </PackageDescription>
<NDC11Code>66096-0753-02</NDC11Code>
<ProductNDC>66096-753</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ohm-cir</ProprietaryName>
<NonProprietaryName>Baryta Iodata, Cactus Grandiflorus, Carbo Vegetabilis, Crataegus Oxyacantha, Curare, Kali Carbonicum, Kalmia Latifolia, Melilotus Officinale, Naja Tripudians, Secale Cornutum, Solanum Nigrum, Spigelia Anthelmia</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>BARIUM IODIDE; SELENICEREUS GRANDIFLORUS STEM; ACTIVATED CHARCOAL; HAWTHORN LEAF WITH FLOWER; TUBOCURARINE CHLORIDE; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; MELILOTUS OFFICINALIS TOP; NAJA NAJA VENOM; CLAVICEPS PURPUREA SCLEROTIUM; SOLANUM NIGRUM TOP; SPIGELIA ANTHELMIA</SubstanceName>
<StrengthNumber>12; 6; 12; 6; 12; 7; 6; 6; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Contraindicaciones: Ninguna reportada.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-757-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-757-02) </PackageDescription>
<NDC11Code>66096-0757-02</NDC11Code>
<ProductNDC>66096-757</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ohm-inma</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Aranea Diadema, Arnica Montana, Asclepias Vincetoxicum, Baptisia Tinctoria, Bryonia Alba, Echinacea Angustifolia, Equisetum Hyemale, Eupatorium Perforliatum, Gelsemium Sempervirens, Hepar Sulphuris Calcareum, Juglans Regia, Phytolacca Decandra, Sanguinaria Canadensis, Sarsaparilla, Sulphur, Zincum Metallicum</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARANEUS DIADEMATUS; ARNICA MONTANA; CYNANCHUM VINCETOXICUM ROOT; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; EQUISETUM HYEMALE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; JUGLANS REGIA LEAF; PHYTOLACCA AMERICANA ROOT; SANGUINARIA CANADENSIS ROOT; SARSAPARILLA; SULFUR; ZINC</SubstanceName>
<StrengthNumber>7; 9; 6; 12; 8; 10; 6; 7; 10; 8; 12; 6; 10; 8; 9; 10; 12</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Contraindicaciones: Ninguna reportada.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66096-758-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (66096-758-02) </PackageDescription>
<NDC11Code>66096-0758-02</NDC11Code>
<ProductNDC>66096-758</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ohm-ost</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calcarea Phosphorica, Causticum, China Officinalis, Colchicum Autumnale, Dulcamara, Ledum Palustre, Rhus Toxicodendron, Symphytum Officinale</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>OHM PHARMA INC.</LabelerName>
<SubstanceName>ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF; COMFREY ROOT</SubstanceName>
<StrengthNumber>4; 12; 12; 12; 12; 6; 7; 12; 8</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Contraindicaciones: Ninguna reportada.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0074-2108-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-2108-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-2108-03</NDC11Code>
<ProductNDC>0074-2108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19930416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-2282-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-2282-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-2282-03</NDC11Code>
<ProductNDC>0074-2282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19930416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-2440-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-2440-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-2440-03</NDC11Code>
<ProductNDC>0074-2440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19930416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3346-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3346-03) * 1.5 mL in 1 SYRINGE (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3346-03</NDC11Code>
<ProductNDC>0074-3346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020517</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3473-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3473-03) * 1.5 mL in 1 SYRINGE (0074-9945-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3473-03</NDC11Code>
<ProductNDC>0074-3473</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020517</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3642-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3642-03) * 1 mL in 1 SYRINGE (0074-9907-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3642-03</NDC11Code>
<ProductNDC>0074-3642</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19890126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019732</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19890127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3683-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3683-03) * 1.5 mL in 1 SYRINGE (0074-9930-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3683-03</NDC11Code>
<ProductNDC>0074-3683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020517</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
</NDCList>