{
"NDC": [
{
"NDCCode": "70518-0200-0",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70518-0200-0) ",
"NDC11Code": "70518-0200-00",
"ProductNDC": "70518-0200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077929",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170206",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam, USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam, USP. The inactive ingredients in meloxicam tablets, USP include starch, microcrystalline cellulose, lactose anhydrous, colloidal silicon dioxide, sodium citrate dihydrate, magnesium stearate."
},
{
"NDCCode": "70518-0200-1",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (70518-0200-1) ",
"NDC11Code": "70518-0200-01",
"ProductNDC": "70518-0200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077929",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170809",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam, USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam, USP. The inactive ingredients in meloxicam tablets, USP include starch, microcrystalline cellulose, lactose anhydrous, colloidal silicon dioxide, sodium citrate dihydrate, magnesium stearate."
},
{
"NDCCode": "70518-0200-2",
"PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (70518-0200-2) ",
"NDC11Code": "70518-0200-02",
"ProductNDC": "70518-0200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077929",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171010",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam, USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam, USP. The inactive ingredients in meloxicam tablets, USP include starch, microcrystalline cellulose, lactose anhydrous, colloidal silicon dioxide, sodium citrate dihydrate, magnesium stearate."
},
{
"NDCCode": "70518-0200-3",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (70518-0200-3) ",
"NDC11Code": "70518-0200-03",
"ProductNDC": "70518-0200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077929",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180830",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam, USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam, USP. The inactive ingredients in meloxicam tablets, USP include starch, microcrystalline cellulose, lactose anhydrous, colloidal silicon dioxide, sodium citrate dihydrate, magnesium stearate."
},
{
"NDCCode": "70518-0200-4",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (70518-0200-4) ",
"NDC11Code": "70518-0200-04",
"ProductNDC": "70518-0200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077929",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200302",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam, USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam, USP. The inactive ingredients in meloxicam tablets, USP include starch, microcrystalline cellulose, lactose anhydrous, colloidal silicon dioxide, sodium citrate dihydrate, magnesium stearate."
},
{
"NDCCode": "15308-0200-0",
"PackageDescription": "25 kg in 1 DRUM (15308-0200-0) ",
"NDC11Code": "15308-0200-00",
"ProductNDC": "15308-0200",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20050101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Aarti Pharmalabs Limited",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2022-11-09",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "01-JAN-05"
},
{
"NDCCode": "15631-0200-0",
"PackageDescription": "100 PELLET in 1 PACKAGE (15631-0200-0) ",
"NDC11Code": "15631-0200-00",
"ProductNDC": "15631-0200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Galanthus Nivalis",
"NonProprietaryName": "Galanthus Nivalis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151025",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "GALANTHUS NIVALIS",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "50090-0200-0",
"PackageDescription": "100 TABLET in 1 BOTTLE (50090-0200-0)",
"NDC11Code": "50090-0200-00",
"ProductNDC": "50090-0200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folic Acid",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040796",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "FOLIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "50384-0200-0",
"PackageDescription": "450 g in 1 BOTTLE (50384-0200-0) ",
"NDC11Code": "50384-0200-00",
"ProductNDC": "50384-0200",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dexrazoxane",
"DosageFormName": "POWDER",
"StartMarketingDate": "20050509",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Sterling Pharma Solutions Limited",
"SubstanceName": "DEXRAZOXANE",
"StrengthNumber": "450",
"StrengthUnit": "g/450g",
"Status": "Unfinished",
"LastUpdate": "2021-04-27",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "09-MAY-05"
},
{
"NDCCode": "50396-0200-0",
"PackageDescription": "10 kg in 1 CONTAINER (50396-0200-0) ",
"NDC11Code": "50396-0200-00",
"ProductNDC": "50396-0200",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140409",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Sanofi Winthrop Industrie",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-02-16",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "09-APR-14"
},
{
"NDCCode": "51927-0200-0",
"PackageDescription": "1 kg in 1 BOTTLE (51927-0200-0) ",
"NDC11Code": "51927-0200-00",
"ProductNDC": "51927-0200",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Acetazolamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20030203",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Professional Compounding Centers of America",
"SubstanceName": "ACETAZOLAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "kg/5kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "03-FEB-03"
},
{
"NDCCode": "52261-0200-0",
"PackageDescription": "15 mL in 1 BOTTLE, WITH APPLICATOR (52261-0200-0)",
"NDC11Code": "52261-0200-00",
"ProductNDC": "52261-0200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fiore Rx Pink Peppermint Pie Antifungal Nail Polish",
"NonProprietaryName": "Undecylenic Acid",
"DosageFormName": "FILM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130423",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "Cosco International, Inc.",
"SubstanceName": "UNDECYLENIC ACID",
"StrengthNumber": ".45",
"StrengthUnit": "g/15mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs."
},
{
"NDCCode": "55488-0200-0",
"PackageDescription": "25 kg in 1 DRUM (55488-0200-0) ",
"NDC11Code": "55488-0200-00",
"ProductNDC": "55488-0200",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "POWDER",
"StartMarketingDate": "19810101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Changzhou Pharmaceutical Factory",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-11-14",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "01-JAN-81"
},
{
"NDCCode": "62147-0200-0",
"PackageDescription": "25 kg in 1 DRUM (62147-0200-0)",
"NDC11Code": "62147-0200-00",
"ProductNDC": "62147-0200",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bexarotene",
"DosageFormName": "POWDER",
"StartMarketingDate": "20091222",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "USV Limited",
"SubstanceName": "BEXAROTENE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "66406-0200-0",
"PackageDescription": "105 mL in 1 BOTTLE, GLASS (66406-0200-0) ",
"NDC11Code": "66406-0200-00",
"ProductNDC": "66406-0200",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Posaconazole",
"DosageFormName": "SUSPENSION",
"StartMarketingDate": "20060915",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Patheon Inc.",
"SubstanceName": "POSACONAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2023-01-24",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "15-SEP-06"
},
{
"NDCCode": "66558-0200-0",
"PackageDescription": "8 kg in 1 CONTAINER (66558-0200-0) ",
"NDC11Code": "66558-0200-00",
"ProductNDC": "66558-0200",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Amoxicillin Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20211120",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Fresenius Kabi iPSUM S.r.l.",
"SubstanceName": "AMOXICILLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2022-06-02",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20-NOV-21"
},
{
"NDCCode": "69218-0200-0",
"PackageDescription": "10 kg in 1 DRUM (69218-0200-0) ",
"NDC11Code": "69218-0200-00",
"ProductNDC": "69218-0200",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sofosbuvir",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Nantong Chanyoo Pharmatech Co., Ltd",
"SubstanceName": "SOFOSBUVIR",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "01-JAN-17"
},
{
"NDCCode": "71057-0200-0",
"PackageDescription": "25 kg in 1 DRUM (71057-0200-0) ",
"NDC11Code": "71057-0200-00",
"ProductNDC": "71057-0200",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Oxytetracycline Dihydrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "YANGZHOU LIBERTY PHARMACEUTICAL CO. LTD",
"SubstanceName": "OXYTETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-01-10",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-JAN-16"
},
{
"NDCCode": "71335-0200-0",
"PackageDescription": "40 CAPSULE in 1 BOTTLE (71335-0200-0) ",
"NDC11Code": "71335-0200-00",
"ProductNDC": "71335-0200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2024-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180226",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "72444-0200-0",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (72444-0200-0) / 30 mL in 1 BOTTLE, GLASS",
"NDC11Code": "72444-0200-00",
"ProductNDC": "72444-0200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crunchi Sunlight Daily Facial Sunscreen Spf 30",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210602",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Cruchi, LLC.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "125",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210602",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "75848-0200-0",
"PackageDescription": "473 mL in 1 BOTTLE (75848-0200-0)",
"NDC11Code": "75848-0200-00",
"ProductNDC": "75848-0200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coconut Lime Antibacterial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Harrison Specialty Co., Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0053-0200-20",
"PackageDescription": "1 KIT in 1 CARTON (0053-0200-20) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) ",
"NDC11Code": "00053-0200-20",
"ProductNDC": "0053-0200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hemgenix",
"NonProprietaryName": "Etranacogene Dezaparvovec",
"DosageFormName": "KIT",
"StartMarketingDate": "20221122",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125772",
"LabelerName": "CSL Behring",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221122",
"SamplePackage": "N",
"IndicationAndUsage": "HEMGENIX is indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: 1 Currently use Factor IX prophylaxis therapy, or, 2 Have current or historical life-threatening hemorrhage, or, 3 Have repeated, serious spontaneous bleeding episodes.",
"Description": "HEMGENIX (etranacogene dezaparvovec-drlb) is an adeno-associated viral vector-based gene therapy for intravenous infusion after dilution. HEMGENIX is a non-replicating recombinant AAV5 containing a codon-optimized DNA sequence of the gain-of-function Padua variant of human Factor IX (variant R338L), under control of a liver-specific promotor 1 (LP1). HEMGENIX has a nominal concentration of 1 × 1013 gc/mL. Each vial contains an extractable volume of no less than 10 mL of HEMGENIX and the following excipients: sucrose (50 mg/mL), polysorbate-20 (0.22 mg/mL), potassium chloride (0.2 mg/mL), potassium phosphate (0.2 mg/mL), sodium chloride (8 mg/mL), and sodium phosphate (1.2 mg/mL). HEMGENIX is sterile, clear and colorless suspension, and contains no preservative. After dilution, HEMGENIX should be clear and colorless suspension."
},
{
"NDCCode": "14335-200-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (14335-200-01) / 30 mL in 1 BOTTLE",
"NDC11Code": "14335-0200-01",
"ProductNDC": "14335-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20230811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217036",
"LabelerName": "Hainan Poly Pharm. Co., Ltd.",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230811",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "Azithromycin for oral suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.0. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin dihydrate USP powder equivalent to 300 mg, 600 mg, 900mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin USP. FDA approved dissolution test specification differs from the USP."
},
{
"NDCCode": "16729-200-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16729-200-01) ",
"NDC11Code": "16729-0200-01",
"ProductNDC": "16729-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202557",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161215",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: : 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg Note :- Not applicable for divided dosesand 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A - potato starch)."
},
{
"NDCCode": "16729-200-16",
"PackageDescription": "500 TABLET in 1 BOTTLE (16729-200-16) ",
"NDC11Code": "16729-0200-16",
"ProductNDC": "16729-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202557",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161215",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: : 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg Note :- Not applicable for divided dosesand 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A - potato starch)."
},
{
"NDCCode": "22840-0200-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0200-2) ",
"NDC11Code": "22840-0200-02",
"ProductNDC": "22840-0200",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Bermuda Grass Pollen",
"NonProprietaryName": "Cynodon Dactylon",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19680915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101836",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "CYNODON DACTYLON POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19680915",
"SamplePackage": "N",
"IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
"Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "22840-0200-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0200-4) ",
"NDC11Code": "22840-0200-04",
"ProductNDC": "22840-0200",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Bermuda Grass Pollen",
"NonProprietaryName": "Cynodon Dactylon",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19680915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101836",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "CYNODON DACTYLON POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19680915",
"SamplePackage": "N",
"IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
"Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "22840-0200-5",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (22840-0200-5) ",
"NDC11Code": "22840-0200-05",
"ProductNDC": "22840-0200",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Bermuda Grass Pollen",
"NonProprietaryName": "Cynodon Dactylon",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19680915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101836",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "CYNODON DACTYLON POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19680915",
"SamplePackage": "N",
"IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
"Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "38739-200-06",
"PackageDescription": "6 CARTON in 1 CARTON (38739-200-06) > 1 SYRINGE in 1 CARTON (38739-200-01) > .3 mL in 1 SYRINGE",
"NDC11Code": "38739-0200-06",
"ProductNDC": "38739-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symjepi",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20171115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207534",
"LabelerName": "Adamis Pharmaceuticals Corporation",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20171115",
"SamplePackage": "N",
"IndicationAndUsage": "SYMJEPI is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. SYMJEPI is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. SYMJEPI is intended for immediate administration as emergency supportive therapy only and is not a substitute for immediate medical care.",
"Description": "Each SYMJEPI pre-filled, syringe delivers a single dose of 0.3 mg of epinephrine from epinephrine injection, USP (0.3mg/0.3 mL). Each SYMJEPI (epinephrine injection, USP) syringe contains 0.8 mL of sterile aqueous solution of epinephrine for intramuscular or subcutaneous administration. The syringe is overfilled for stability purposes; more than half of the solution remains in the syringe after use and CANNOT BE REUSED. Each 0.3 mL contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine (a non-selective alpha and beta-adrenergic receptor agonist) designated chemically as (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol and has the following structure. The molecular weight of epinephrine is 183.20. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from formation of melanin. Replace SYMJEPI if the solution appears discolored (pinkish or brown color), cloudy, or contains particles."
},
{
"NDCCode": "38739-200-12",
"PackageDescription": "6 CARTON in 1 CARTON (38739-200-12) > 2 SYRINGE in 1 CARTON (38739-200-02) > .3 mL in 1 SYRINGE",
"NDC11Code": "38739-0200-12",
"ProductNDC": "38739-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symjepi",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20171115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207534",
"LabelerName": "Adamis Pharmaceuticals Corporation",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20171115",
"SamplePackage": "N",
"IndicationAndUsage": "SYMJEPI is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. SYMJEPI is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. SYMJEPI is intended for immediate administration as emergency supportive therapy only and is not a substitute for immediate medical care.",
"Description": "Each SYMJEPI pre-filled, syringe delivers a single dose of 0.3 mg of epinephrine from epinephrine injection, USP (0.3mg/0.3 mL). Each SYMJEPI (epinephrine injection, USP) syringe contains 0.8 mL of sterile aqueous solution of epinephrine for intramuscular or subcutaneous administration. The syringe is overfilled for stability purposes; more than half of the solution remains in the syringe after use and CANNOT BE REUSED. Each 0.3 mL contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine (a non-selective alpha and beta-adrenergic receptor agonist) designated chemically as (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol and has the following structure. The molecular weight of epinephrine is 183.20. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from formation of melanin. Replace SYMJEPI if the solution appears discolored (pinkish or brown color), cloudy, or contains particles."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70518-0200-0</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (70518-0200-0) </PackageDescription>
<NDC11Code>70518-0200-00</NDC11Code>
<ProductNDC>70518-0200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077929</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).</IndicationAndUsage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam, USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam, USP. The inactive ingredients in meloxicam tablets, USP include starch, microcrystalline cellulose, lactose anhydrous, colloidal silicon dioxide, sodium citrate dihydrate, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70518-0200-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (70518-0200-1) </PackageDescription>
<NDC11Code>70518-0200-01</NDC11Code>
<ProductNDC>70518-0200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077929</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).</IndicationAndUsage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam, USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam, USP. The inactive ingredients in meloxicam tablets, USP include starch, microcrystalline cellulose, lactose anhydrous, colloidal silicon dioxide, sodium citrate dihydrate, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70518-0200-2</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (70518-0200-2) </PackageDescription>
<NDC11Code>70518-0200-02</NDC11Code>
<ProductNDC>70518-0200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077929</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).</IndicationAndUsage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam, USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam, USP. The inactive ingredients in meloxicam tablets, USP include starch, microcrystalline cellulose, lactose anhydrous, colloidal silicon dioxide, sodium citrate dihydrate, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70518-0200-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (70518-0200-3) </PackageDescription>
<NDC11Code>70518-0200-03</NDC11Code>
<ProductNDC>70518-0200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077929</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).</IndicationAndUsage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam, USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam, USP. The inactive ingredients in meloxicam tablets, USP include starch, microcrystalline cellulose, lactose anhydrous, colloidal silicon dioxide, sodium citrate dihydrate, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70518-0200-4</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (70518-0200-4) </PackageDescription>
<NDC11Code>70518-0200-04</NDC11Code>
<ProductNDC>70518-0200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077929</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).</IndicationAndUsage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam, USP for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam, USP. The inactive ingredients in meloxicam tablets, USP include starch, microcrystalline cellulose, lactose anhydrous, colloidal silicon dioxide, sodium citrate dihydrate, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>15308-0200-0</NDCCode>
<PackageDescription>25 kg in 1 DRUM (15308-0200-0) </PackageDescription>
<NDC11Code>15308-0200-00</NDC11Code>
<ProductNDC>15308-0200</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20050101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Aarti Pharmalabs Limited</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-11-09</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-05</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>15631-0200-0</NDCCode>
<PackageDescription>100 PELLET in 1 PACKAGE (15631-0200-0) </PackageDescription>
<NDC11Code>15631-0200-00</NDC11Code>
<ProductNDC>15631-0200</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Galanthus Nivalis</ProprietaryName>
<NonProprietaryName>Galanthus Nivalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151025</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>GALANTHUS NIVALIS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-0200-0</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (50090-0200-0)</PackageDescription>
<NDC11Code>50090-0200-00</NDC11Code>
<ProductNDC>50090-0200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folic Acid</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040796</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>FOLIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50384-0200-0</NDCCode>
<PackageDescription>450 g in 1 BOTTLE (50384-0200-0) </PackageDescription>
<NDC11Code>50384-0200-00</NDC11Code>
<ProductNDC>50384-0200</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dexrazoxane</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20050509</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Sterling Pharma Solutions Limited</LabelerName>
<SubstanceName>DEXRAZOXANE</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>g/450g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2021-04-27</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>09-MAY-05</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>50396-0200-0</NDCCode>
<PackageDescription>10 kg in 1 CONTAINER (50396-0200-0) </PackageDescription>
<NDC11Code>50396-0200-00</NDC11Code>
<ProductNDC>50396-0200</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140409</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Sanofi Winthrop Industrie</LabelerName>
<SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-02-16</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>09-APR-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51927-0200-0</NDCCode>
<PackageDescription>1 kg in 1 BOTTLE (51927-0200-0) </PackageDescription>
<NDC11Code>51927-0200-00</NDC11Code>
<ProductNDC>51927-0200</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Acetazolamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20030203</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Professional Compounding Centers of America</LabelerName>
<SubstanceName>ACETAZOLAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>kg/5kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-FEB-03</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>52261-0200-0</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, WITH APPLICATOR (52261-0200-0)</PackageDescription>
<NDC11Code>52261-0200-00</NDC11Code>
<ProductNDC>52261-0200</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fiore Rx Pink Peppermint Pie Antifungal Nail Polish</ProprietaryName>
<NonProprietaryName>Undecylenic Acid</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130423</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>Cosco International, Inc.</LabelerName>
<SubstanceName>UNDECYLENIC ACID</SubstanceName>
<StrengthNumber>.45</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>When using this product avoid contact with eyes. Stop use and ask a doctor if irritation occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55488-0200-0</NDCCode>
<PackageDescription>25 kg in 1 DRUM (55488-0200-0) </PackageDescription>
<NDC11Code>55488-0200-00</NDC11Code>
<ProductNDC>55488-0200</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19810101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Changzhou Pharmaceutical Factory</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-11-14</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-81</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>62147-0200-0</NDCCode>
<PackageDescription>25 kg in 1 DRUM (62147-0200-0)</PackageDescription>
<NDC11Code>62147-0200-00</NDC11Code>
<ProductNDC>62147-0200</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bexarotene</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20091222</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>USV Limited</LabelerName>
<SubstanceName>BEXAROTENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>66406-0200-0</NDCCode>
<PackageDescription>105 mL in 1 BOTTLE, GLASS (66406-0200-0) </PackageDescription>
<NDC11Code>66406-0200-00</NDC11Code>
<ProductNDC>66406-0200</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Posaconazole</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<StartMarketingDate>20060915</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Patheon Inc.</LabelerName>
<SubstanceName>POSACONAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-01-24</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-SEP-06</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>66558-0200-0</NDCCode>
<PackageDescription>8 kg in 1 CONTAINER (66558-0200-0) </PackageDescription>
<NDC11Code>66558-0200-00</NDC11Code>
<ProductNDC>66558-0200</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Amoxicillin Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20211120</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Fresenius Kabi iPSUM S.r.l.</LabelerName>
<SubstanceName>AMOXICILLIN SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-06-02</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-NOV-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>69218-0200-0</NDCCode>
<PackageDescription>10 kg in 1 DRUM (69218-0200-0) </PackageDescription>
<NDC11Code>69218-0200-00</NDC11Code>
<ProductNDC>69218-0200</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sofosbuvir</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Nantong Chanyoo Pharmatech Co., Ltd</LabelerName>
<SubstanceName>SOFOSBUVIR</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71057-0200-0</NDCCode>
<PackageDescription>25 kg in 1 DRUM (71057-0200-0) </PackageDescription>
<NDC11Code>71057-0200-00</NDC11Code>
<ProductNDC>71057-0200</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxytetracycline Dihydrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>YANGZHOU LIBERTY PHARMACEUTICAL CO. LTD</LabelerName>
<SubstanceName>OXYTETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-10</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71335-0200-0</NDCCode>
<PackageDescription>40 CAPSULE in 1 BOTTLE (71335-0200-0) </PackageDescription>
<NDC11Code>71335-0200-00</NDC11Code>
<ProductNDC>71335-0200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci:Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg- black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg- black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto-octopyranoside monohydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>72444-0200-0</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (72444-0200-0) / 30 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>72444-0200-00</NDC11Code>
<ProductNDC>72444-0200</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crunchi Sunlight Daily Facial Sunscreen Spf 30</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210602</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Cruchi, LLC.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75848-0200-0</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (75848-0200-0)</PackageDescription>
<NDC11Code>75848-0200-00</NDC11Code>
<ProductNDC>75848-0200</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coconut Lime Antibacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Harrison Specialty Co., Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0053-0200-20</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0053-0200-20) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) </PackageDescription>
<NDC11Code>00053-0200-20</NDC11Code>
<ProductNDC>0053-0200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hemgenix</ProprietaryName>
<NonProprietaryName>Etranacogene Dezaparvovec</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20221122</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125772</ApplicationNumber>
<LabelerName>CSL Behring</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HEMGENIX is indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: 1 Currently use Factor IX prophylaxis therapy, or, 2 Have current or historical life-threatening hemorrhage, or, 3 Have repeated, serious spontaneous bleeding episodes.</IndicationAndUsage>
<Description>HEMGENIX (etranacogene dezaparvovec-drlb) is an adeno-associated viral vector-based gene therapy for intravenous infusion after dilution. HEMGENIX is a non-replicating recombinant AAV5 containing a codon-optimized DNA sequence of the gain-of-function Padua variant of human Factor IX (variant R338L), under control of a liver-specific promotor 1 (LP1). HEMGENIX has a nominal concentration of 1 × 1013 gc/mL. Each vial contains an extractable volume of no less than 10 mL of HEMGENIX and the following excipients: sucrose (50 mg/mL), polysorbate-20 (0.22 mg/mL), potassium chloride (0.2 mg/mL), potassium phosphate (0.2 mg/mL), sodium chloride (8 mg/mL), and sodium phosphate (1.2 mg/mL). HEMGENIX is sterile, clear and colorless suspension, and contains no preservative. After dilution, HEMGENIX should be clear and colorless suspension.</Description>
</NDC>
<NDC>
<NDCCode>14335-200-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (14335-200-01) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>14335-0200-01</NDC11Code>
<ProductNDC>14335-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217036</ApplicationNumber>
<LabelerName>Hainan Poly Pharm. Co., Ltd.</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin for oral suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.0. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin dihydrate USP powder equivalent to 300 mg, 600 mg, 900mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin USP. FDA approved dissolution test specification differs from the USP.</Description>
</NDC>
<NDC>
<NDCCode>16729-200-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16729-200-01) </PackageDescription>
<NDC11Code>16729-0200-01</NDC11Code>
<ProductNDC>16729-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202557</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: : 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg Note :- Not applicable for divided dosesand 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A - potato starch).</Description>
</NDC>
<NDC>
<NDCCode>16729-200-16</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16729-200-16) </PackageDescription>
<NDC11Code>16729-0200-16</NDC11Code>
<ProductNDC>16729-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202557</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: : 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg Note :- Not applicable for divided dosesand 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A - potato starch).</Description>
</NDC>
<NDC>
<NDCCode>22840-0200-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-0200-2) </PackageDescription>
<NDC11Code>22840-0200-02</NDC11Code>
<ProductNDC>22840-0200</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Bermuda Grass Pollen</ProprietaryName>
<NonProprietaryName>Cynodon Dactylon</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19680915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101836</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>CYNODON DACTYLON POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19680915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
<Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>22840-0200-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0200-4) </PackageDescription>
<NDC11Code>22840-0200-04</NDC11Code>
<ProductNDC>22840-0200</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Bermuda Grass Pollen</ProprietaryName>
<NonProprietaryName>Cynodon Dactylon</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19680915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101836</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>CYNODON DACTYLON POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19680915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
<Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>22840-0200-5</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (22840-0200-5) </PackageDescription>
<NDC11Code>22840-0200-05</NDC11Code>
<ProductNDC>22840-0200</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Bermuda Grass Pollen</ProprietaryName>
<NonProprietaryName>Cynodon Dactylon</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19680915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101836</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>CYNODON DACTYLON POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19680915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
<Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>38739-200-06</NDCCode>
<PackageDescription>6 CARTON in 1 CARTON (38739-200-06) > 1 SYRINGE in 1 CARTON (38739-200-01) > .3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>38739-0200-06</NDC11Code>
<ProductNDC>38739-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symjepi</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207534</ApplicationNumber>
<LabelerName>Adamis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SYMJEPI is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. SYMJEPI is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. SYMJEPI is intended for immediate administration as emergency supportive therapy only and is not a substitute for immediate medical care.</IndicationAndUsage>
<Description>Each SYMJEPI pre-filled, syringe delivers a single dose of 0.3 mg of epinephrine from epinephrine injection, USP (0.3mg/0.3 mL). Each SYMJEPI (epinephrine injection, USP) syringe contains 0.8 mL of sterile aqueous solution of epinephrine for intramuscular or subcutaneous administration. The syringe is overfilled for stability purposes; more than half of the solution remains in the syringe after use and CANNOT BE REUSED. Each 0.3 mL contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine (a non-selective alpha and beta-adrenergic receptor agonist) designated chemically as (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol and has the following structure. The molecular weight of epinephrine is 183.20. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from formation of melanin. Replace SYMJEPI if the solution appears discolored (pinkish or brown color), cloudy, or contains particles.</Description>
</NDC>
<NDC>
<NDCCode>38739-200-12</NDCCode>
<PackageDescription>6 CARTON in 1 CARTON (38739-200-12) > 2 SYRINGE in 1 CARTON (38739-200-02) > .3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>38739-0200-12</NDC11Code>
<ProductNDC>38739-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symjepi</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207534</ApplicationNumber>
<LabelerName>Adamis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SYMJEPI is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. SYMJEPI is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. SYMJEPI is intended for immediate administration as emergency supportive therapy only and is not a substitute for immediate medical care.</IndicationAndUsage>
<Description>Each SYMJEPI pre-filled, syringe delivers a single dose of 0.3 mg of epinephrine from epinephrine injection, USP (0.3mg/0.3 mL). Each SYMJEPI (epinephrine injection, USP) syringe contains 0.8 mL of sterile aqueous solution of epinephrine for intramuscular or subcutaneous administration. The syringe is overfilled for stability purposes; more than half of the solution remains in the syringe after use and CANNOT BE REUSED. Each 0.3 mL contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine (a non-selective alpha and beta-adrenergic receptor agonist) designated chemically as (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol and has the following structure. The molecular weight of epinephrine is 183.20. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from formation of melanin. Replace SYMJEPI if the solution appears discolored (pinkish or brown color), cloudy, or contains particles.</Description>
</NDC>
</NDCList>