{
"NDC": [
{
"NDCCode": "75447-224-96",
"PackageDescription": "222 mL in 1 BOTTLE, PUMP (75447-224-96) ",
"NDC11Code": "75447-0224-96",
"ProductNDC": "75447-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foaming Hand",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "OptiSource International, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "to decrease bacteria on the skin that could cause disease."
},
{
"NDCCode": "11344-224-96",
"PackageDescription": "222 mL in 1 BOTTLE, PUMP (11344-224-96) ",
"NDC11Code": "11344-0224-96",
"ProductNDC": "11344-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foaming Hand",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180208",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180208",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "36800-224-80",
"PackageDescription": "1 BOTTLE in 1 CARTON (36800-224-80) > 96 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "36800-0224-80",
"ProductNDC": "36800-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Anti Diarrheal",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075232",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20071112",
"SamplePackage": "N"
},
{
"NDCCode": "41250-224-01",
"PackageDescription": "2 BOTTLE in 1 CARTON (41250-224-01) > 96 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "41250-0224-01",
"ProductNDC": "41250-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Diarrheal",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075232",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20030430",
"SamplePackage": "N"
},
{
"NDCCode": "41250-224-80",
"PackageDescription": "1 BOTTLE in 1 CARTON (41250-224-80) > 96 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "41250-0224-80",
"ProductNDC": "41250-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Diarrheal",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075232",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20030430",
"SamplePackage": "N"
},
{
"NDCCode": "42507-224-80",
"PackageDescription": "1 BOTTLE in 1 CARTON (42507-224-80) > 96 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "42507-0224-80",
"ProductNDC": "42507-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Diarrheal",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075232",
"LabelerName": "HyVee Inc",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20030321",
"SamplePackage": "N"
},
{
"NDCCode": "55316-224-80",
"PackageDescription": "1 BOTTLE in 1 CARTON (55316-224-80) > 96 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "55316-0224-80",
"ProductNDC": "55316-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Healthy Accents Anti Diarrheal",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075232",
"LabelerName": "DZA Brands LLC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "56062-224-80",
"PackageDescription": "1 BOTTLE in 1 CARTON (56062-224-80) > 96 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "56062-0224-80",
"ProductNDC": "56062-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Diarrheal",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075232",
"LabelerName": "Publix Super Markets Inc",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050113",
"SamplePackage": "N",
"IndicationAndUsage": "controls symptoms of diarrhea, including Travelers’ Diarrhea."
},
{
"NDCCode": "68391-224-01",
"PackageDescription": "2 BOTTLE in 1 CARTON (68391-224-01) > 96 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "68391-0224-01",
"ProductNDC": "68391-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Berkley And Jensen Anti Diarrheal",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075232",
"LabelerName": "BJWC",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20030419",
"SamplePackage": "N"
},
{
"NDCCode": "57664-224-88",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-224-88) ",
"NDC11Code": "57664-0224-88",
"ProductNDC": "57664-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090659",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090512",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. In addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and D&C Red #30 aluminum lake, the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue #2 aluminum lake, the 20 mg tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet contains FD&C Blue #2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 8.96 mg, 13.5 mg, 17.93 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "58284-224-01",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (58284-224-01) / .48 mL in 1 SYRINGE, GLASS",
"NDC11Code": "58284-0224-01",
"ProductNDC": "58284-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brixadi",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230606",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210136",
"LabelerName": "Braeburn Inc.",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "24",
"StrengthUnit": "mg/.48mL",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support.",
"Description": "BRIXADI (buprenorphine) extended-release injection is a sterile, yellowish to yellow clear liquid provided in a single-dose, pre-filled syringe intended for subcutaneous injection only. BRIXADI is designed to deliver buprenorphine at a controlled rate over either one week or one month. The active ingredient in BRIXADI is buprenorphine free base, a partial opioid agonist. BRIXADI is provided in multiple doses with two durations (weekly and monthly). : 1 BRIXADI (weekly; 8, 16, 24, 32 mg) consists of 50 mg/mL buprenorphine. The inactive ingredients include dehydrated alcohol (12% v/v), glycerol dioleate (43% v/v), and soybean phosphatidylcholine (41% w/v)., 2 BRIXADI (monthly; 64, 96, 128 mg) consists of 356 mg/mL buprenorphine. The inactive ingredients include glycerol dioleate (24% v/v), methylpyrrolidone (31% v/v), and soybean phosphatidylcholine (15% w/v)."
},
{
"NDCCode": "59651-224-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (59651-224-01) ",
"NDC11Code": "59651-0224-01",
"ProductNDC": "59651-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pilocarpine Hydrochloride",
"NonProprietaryName": "Pilocarpine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190813",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212377",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PILOCARPINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190813",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGEPilocarpine hydrochloride tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.",
"Description": "DESCRIPTION. Pilocarpine hydrochloride tablets, USP contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a white or almost white, crystalline powder or colorless crystals, hygroscopic which is very soluble in water and freely soluble in ethanol (96 percent). Pilocarpine hydrochloride, with a chemical name of (3S-cis)-2(3H)-Furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl] monohydrochloride, has a molecular weight of 244.72. Each 5 mg pilocarpine hydrochloride tablet, USP for oral administration contains 5 mg of pilocarpine hydrochloride USP. Inactive ingredients in the tablet are: hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid and titanium dioxide. Each 7.5 mg pilocarpine hydrochloride tablet, USP for oral administration contains 7.5 mg of pilocarpine hydrochloride USP. Inactive ingredients in the tablet are: FD&C blue # 2, hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "75447-100-02",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (75447-100-02) ",
"NDC11Code": "75447-0100-02",
"ProductNDC": "75447-100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Optimal Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200609",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Optisource International Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N"
},
{
"NDCCode": "75447-200-02",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (75447-200-02) ",
"NDC11Code": "75447-0200-02",
"ProductNDC": "75447-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Optimal Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200609",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Optisource International Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N"
},
{
"NDCCode": "75447-200-50",
"PackageDescription": "50 mL in 1 BOTTLE, DISPENSING (75447-200-50) ",
"NDC11Code": "75447-0200-50",
"ProductNDC": "75447-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Optimal Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200609",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Optisource International Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For hand sanitizing to decrease bacteria on the skin Recommended for repeat use."
},
{
"NDCCode": "0054-0650-25",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0054-0650-25) ",
"NDC11Code": "00054-0650-25",
"ProductNDC": "0054-0650",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, Caffeine And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Acetaminophen, Caffeine And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215138",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "50; 300; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220509",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in two strength combinations in capsule form for oral administration. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/300 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….300 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….325 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, USP (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. MW = 224.26. Acetaminophen, USP (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MW = 151.16. Caffeine, USP (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:. C8H10N4O2. MW = 194.19. Codeine Phosphate, USP (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula. C18H21NO3H3PO41/2H2O. MW = 406.37. Inactive Ingredients: pregelatinized starch. colloidal silicon dioxide, magnesium stearate. The capsule cap is printed with white ink. The white ink contains shellac glaze, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone. The capsule body is printed with black ink. The black ink contains shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide. The capsule shell contains: gelatin, titanium dioxide for both strengths and FD&C red #40, FD&C blue #1 in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40mg/30mg and FD&C red #3, FD&C blue #2, red iron oxide, yellow iron oxide in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40mg/30mg."
},
{
"NDCCode": "0054-3000-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0054-3000-01) ",
"NDC11Code": "00054-3000-01",
"ProductNDC": "0054-3000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, Caffeine And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Acetaminophen, Caffeine And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215138",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "50; 325; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220509",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in two strength combinations in capsule form for oral administration. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/300 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….300 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….325 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, USP (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. MW = 224.26. Acetaminophen, USP (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MW = 151.16. Caffeine, USP (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:. C8H10N4O2. MW = 194.19. Codeine Phosphate, USP (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula. C18H21NO3H3PO41/2H2O. MW = 406.37. Inactive Ingredients: pregelatinized starch. colloidal silicon dioxide, magnesium stearate. The capsule cap is printed with white ink. The white ink contains shellac glaze, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone. The capsule body is printed with black ink. The black ink contains shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide. The capsule shell contains: gelatin, titanium dioxide for both strengths and FD&C red #40, FD&C blue #1 in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40mg/30mg and FD&C red #3, FD&C blue #2, red iron oxide, yellow iron oxide in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40mg/30mg."
},
{
"NDCCode": "0078-0630-35",
"PackageDescription": "224 PACKAGE in 1 BOX, UNIT-DOSE (0078-0630-35) > 56 BLISTER PACK in 1 PACKAGE (0078-0630-56) > 4 CAPSULE in 1 BLISTER PACK (0078-0630-11) ",
"NDC11Code": "00078-0630-35",
"ProductNDC": "0078-0630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobi Podhaler",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL; RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130322",
"EndMarketingDate": "20220731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201688",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "28",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130322",
"EndMarketingDatePackage": "20220731",
"SamplePackage": "N"
},
{
"NDCCode": "0143-9289-01",
"PackageDescription": "1 VIAL in 1 CARTON (0143-9289-01) / 5 mL in 1 VIAL",
"NDC11Code": "00143-9289-01",
"ProductNDC": "0143-9289",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol Valerate",
"NonProprietaryName": "Estradiol Valerate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20200421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203723",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ESTRADIOL VALERATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200421",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol Valerate Injection, USP is indicated in the: : 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause. , 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. , 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. , 4 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). .",
"Description": "Estradiol Valerate Injection, USP contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg Estradiol Valerate, USP in a vehicle containing 5 mg Chlorobutanol, NF (chloral derivative/preservative) and 895 mg Sesame Oil, NF; 20 mg Estradiol Valerate, USP in a vehicle containing 224 mg Benzyl Benzoate, USP, 20 mg Benzyl Alcohol, NF (preservative), and 726 mg Castor Oil, USP; 40 mg Estradiol Valerate, USP in a vehicle containing 447 mg Benzyl Benzoate, USP, 20 mg Benzyl Alcohol, NF, and 533 mg Castor Oil, USP. Estradiol Valerate, USP is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula:. C23H32O3 MW 356.50."
},
{
"NDCCode": "0143-9290-01",
"PackageDescription": "1 VIAL in 1 CARTON (0143-9290-01) / 5 mL in 1 VIAL",
"NDC11Code": "00143-9290-01",
"ProductNDC": "0143-9290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol Valerate",
"NonProprietaryName": "Estradiol Valerate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20200421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203723",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ESTRADIOL VALERATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200421",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol Valerate Injection, USP is indicated in the: : 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause. , 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. , 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. , 4 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). .",
"Description": "Estradiol Valerate Injection, USP contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg Estradiol Valerate, USP in a vehicle containing 5 mg Chlorobutanol, NF (chloral derivative/preservative) and 895 mg Sesame Oil, NF; 20 mg Estradiol Valerate, USP in a vehicle containing 224 mg Benzyl Benzoate, USP, 20 mg Benzyl Alcohol, NF (preservative), and 726 mg Castor Oil, USP; 40 mg Estradiol Valerate, USP in a vehicle containing 447 mg Benzyl Benzoate, USP, 20 mg Benzyl Alcohol, NF, and 533 mg Castor Oil, USP. Estradiol Valerate, USP is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula:. C23H32O3 MW 356.50."
},
{
"NDCCode": "0143-9291-01",
"PackageDescription": "1 VIAL in 1 CARTON (0143-9291-01) / 5 mL in 1 VIAL",
"NDC11Code": "00143-9291-01",
"ProductNDC": "0143-9291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol Valerate",
"NonProprietaryName": "Estradiol Valerate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20200421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203723",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ESTRADIOL VALERATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200421",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol Valerate Injection, USP is indicated in the: : 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause. , 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. , 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. , 4 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). .",
"Description": "Estradiol Valerate Injection, USP contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg Estradiol Valerate, USP in a vehicle containing 5 mg Chlorobutanol, NF (chloral derivative/preservative) and 895 mg Sesame Oil, NF; 20 mg Estradiol Valerate, USP in a vehicle containing 224 mg Benzyl Benzoate, USP, 20 mg Benzyl Alcohol, NF (preservative), and 726 mg Castor Oil, USP; 40 mg Estradiol Valerate, USP in a vehicle containing 447 mg Benzyl Benzoate, USP, 20 mg Benzyl Alcohol, NF, and 533 mg Castor Oil, USP. Estradiol Valerate, USP is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula:. C23H32O3 MW 356.50."
},
{
"NDCCode": "0338-0673-04",
"PackageDescription": "1000 mL in 1 BAG (0338-0673-04) ",
"NDC11Code": "00338-0673-04",
"ProductNDC": "0338-0673",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride In Dextrose And Sodium Chloride",
"NonProprietaryName": "Potassium Chloride, Dextrose Monohydrate And Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19790202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018008",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE",
"StrengthNumber": "224; 5; 450",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19790202",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Chloride in Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories.",
"Description": "Potassium Chloride in Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Dextrose is derived from corn. The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-0685-04",
"PackageDescription": "1000 mL in 1 BAG (0338-0685-04)",
"NDC11Code": "00338-0685-04",
"ProductNDC": "0338-0685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride In Dextrose",
"NonProprietaryName": "Potassium Chloride And Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19790201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017634",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE",
"StrengthNumber": "5; 224",
"StrengthUnit": "g/100mL; mg/100mL",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-12-19"
},
{
"NDCCode": "0404-9936-10",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9936-10) / 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00404-9936-10",
"ProductNDC": "0404-9936",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088901",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "meq/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220113",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.",
"Description": "Potassium Chloride for Injection Concentrate, USP is a sterile, nonpyrogenic concentrated solution of Potassium Chloride, USP in Water for Injection to be administered by intravenous infusion only after dilution in a larger volume of fluid. Each mL of Potassium Chloride for Injection Concentrate contains 2 mEq of K+ and Cl– equivalent to 149 mg of potassium chloride and has an osmolarity of 4000 mOsmol/L (calc). A more concentrated Potassium Chloride for Injection Concentrate is also available. Each mL of this injection contains 3 mEq of K+ and Cl– equivalent to 224 mg of potassium chloride and has an osmolarity of 6000 mOsmol/L(calc). pH (4.0-8.0) may have been adjusted with hydrochloric acid and if necessary, potassium hydroxide. Some packages are intended for multiple dose use and contain preservatives (0.05% methylparaben and 0.005% propylparaben). A summary of the available products is presented in the HOW SUPPLIED section. Potassium Chloride for Injection Concentrate (appropriately diluted) is a parenteral fluid and electrolyte replenisher."
},
{
"NDCCode": "0404-9936-20",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9936-20) / 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00404-9936-20",
"ProductNDC": "0404-9936",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088901",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "meq/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220113",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.",
"Description": "Potassium Chloride for Injection Concentrate, USP is a sterile, nonpyrogenic concentrated solution of Potassium Chloride, USP in Water for Injection to be administered by intravenous infusion only after dilution in a larger volume of fluid. Each mL of Potassium Chloride for Injection Concentrate contains 2 mEq of K+ and Cl– equivalent to 149 mg of potassium chloride and has an osmolarity of 4000 mOsmol/L (calc). A more concentrated Potassium Chloride for Injection Concentrate is also available. Each mL of this injection contains 3 mEq of K+ and Cl– equivalent to 224 mg of potassium chloride and has an osmolarity of 6000 mOsmol/L(calc). pH (4.0-8.0) may have been adjusted with hydrochloric acid and if necessary, potassium hydroxide. Some packages are intended for multiple dose use and contain preservatives (0.05% methylparaben and 0.005% propylparaben). A summary of the available products is presented in the HOW SUPPLIED section. Potassium Chloride for Injection Concentrate (appropriately diluted) is a parenteral fluid and electrolyte replenisher."
},
{
"NDCCode": "0409-0032-01",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-0032-01) / 15 mL in 1 VIAL, SINGLE-DOSE (0409-0032-10) ",
"NDC11Code": "00409-0032-01",
"ProductNDC": "0409-0032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217459",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250929",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Phosphates Injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .",
"Description": "Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as 15 mL single-dose vials. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "0409-7295-01",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-7295-01) / 15 mL in 1 VIAL, SINGLE-DOSE (0409-7295-11) ",
"NDC11Code": "00409-7295-01",
"ProductNDC": "0409-7295",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphate, Monobasic And Potassium Phosphate, Dibasic",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050826",
"EndMarketingDate": "20260201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DIBASIC POTASSIUM PHOSPHATE; MONOBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "236; 224",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050826",
"EndMarketingDatePackage": "20260201",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of potassium (K+ 4.4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions. Safety has not been established for parenteral nutrition in pediatric patients due to the risk of aluminum toxicity. (See WARNINGS).",
"Description": "Potassium Phosphates Injection, USP 3 mM P/mL (millimoles/mL) is a sterile, nonpyrogenic, concentrated solution containing a mixture of mono- and dibasic potassium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each milliliter contains 224 mg of monobasic potassium phosphate, anhydrous and 236 mg of dibasic potassium phosphate, anhydrous. One mM of phosphorus weighs 31 mg and the product provides 93 mg (approximately 3 mM) of phosphorus/mL, plus 170.3 mg (4.4 mEq) of potassium/mL. Note: 1 mM P=1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The osmolar concentration is 7.4 mOsmol/mL (calc.). The solution is intended as an alternative to sodium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. Monobasic Potassium Phosphate, NF (monopotassium phosphate), anhydrous is chemically designated KH2PO4, colorless crystals or white granular powder freely soluble in water. Dibasic Potassium Phosphate, USP (dipotassium phosphate), anhydrous is chemically designated K2HPO4, white granules very soluble in water."
},
{
"NDCCode": "0409-7295-17",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-7295-17) > 15 mL in 1 VIAL, SINGLE-DOSE (0409-7295-27)",
"NDC11Code": "00409-7295-17",
"ProductNDC": "0409-7295",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphate, Monobasic And Potassium Phosphate, Dibasic",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-08-23",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-7996-09",
"PackageDescription": "12 POUCH in 1 CASE (0409-7996-09) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG",
"NDC11Code": "00409-7996-09",
"ProductNDC": "0409-7996",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride In Dextrose",
"NonProprietaryName": "Dextrose Monohydrate And Potassium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19800529",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018371",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE",
"StrengthNumber": "5; .224",
"StrengthUnit": "g/100mL; g/100mL",
"Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19800529",
"SamplePackage": "N"
},
{
"NDCCode": "0517-0420-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0517-0420-01) / 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00517-0420-01",
"ProductNDC": "0517-0420",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol Valerate",
"NonProprietaryName": "Estradiol Valerate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090920",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "ESTRADIOL VALERATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200301",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol Valerate Injection is indicated in the. 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).",
"Description": "Estradiol Valerate Injection, USP contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to yellow. Formulations (per mL): 20 mg estradiol valerate in a vehicle containing 224 mg benzyl benzoate, 20 mg benzyl alcohol (preservative), and castor oil; 40 mg estradiol valerate in a vehicle containing 447 mg benzyl benzoate, 20 mg benzyl alcohol, and castor oil. Estradiol valerate is designated chemically as estra-1,3,5(10) – triene-3, 17 – diol(17 β) - , 17-pentanoate. Graphic formula. C23H32O3 MW 356.50."
}
]
}
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<NDCList>
<NDC>
<NDCCode>75447-224-96</NDCCode>
<PackageDescription>222 mL in 1 BOTTLE, PUMP (75447-224-96) </PackageDescription>
<NDC11Code>75447-0224-96</NDC11Code>
<ProductNDC>75447-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foaming Hand</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>OptiSource International, Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to decrease bacteria on the skin that could cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11344-224-96</NDCCode>
<PackageDescription>222 mL in 1 BOTTLE, PUMP (11344-224-96) </PackageDescription>
<NDC11Code>11344-0224-96</NDC11Code>
<ProductNDC>11344-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foaming Hand</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180208</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-224-80</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (36800-224-80) > 96 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>36800-0224-80</NDC11Code>
<ProductNDC>36800-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075232</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41250-224-01</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (41250-224-01) > 96 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>41250-0224-01</NDC11Code>
<ProductNDC>41250-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075232</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41250-224-80</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41250-224-80) > 96 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>41250-0224-80</NDC11Code>
<ProductNDC>41250-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075232</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42507-224-80</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (42507-224-80) > 96 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>42507-0224-80</NDC11Code>
<ProductNDC>42507-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075232</ApplicationNumber>
<LabelerName>HyVee Inc</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55316-224-80</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55316-224-80) > 96 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>55316-0224-80</NDC11Code>
<ProductNDC>55316-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Healthy Accents Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075232</ApplicationNumber>
<LabelerName>DZA Brands LLC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>56062-224-80</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (56062-224-80) > 96 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>56062-0224-80</NDC11Code>
<ProductNDC>56062-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075232</ApplicationNumber>
<LabelerName>Publix Super Markets Inc</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>controls symptoms of diarrhea, including Travelers’ Diarrhea.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68391-224-01</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (68391-224-01) > 96 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>68391-0224-01</NDC11Code>
<ProductNDC>68391-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Berkley And Jensen Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075232</ApplicationNumber>
<LabelerName>BJWC</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57664-224-88</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57664-224-88) </PackageDescription>
<NDC11Code>57664-0224-88</NDC11Code>
<ProductNDC>57664-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090659</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. In addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and D&C Red #30 aluminum lake, the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue #2 aluminum lake, the 20 mg tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet contains FD&C Blue #2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 8.96 mg, 13.5 mg, 17.93 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>58284-224-01</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (58284-224-01) / .48 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>58284-0224-01</NDC11Code>
<ProductNDC>58284-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brixadi</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230606</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210136</ApplicationNumber>
<LabelerName>Braeburn Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>24</StrengthNumber>
<StrengthUnit>mg/.48mL</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support.</IndicationAndUsage>
<Description>BRIXADI (buprenorphine) extended-release injection is a sterile, yellowish to yellow clear liquid provided in a single-dose, pre-filled syringe intended for subcutaneous injection only. BRIXADI is designed to deliver buprenorphine at a controlled rate over either one week or one month. The active ingredient in BRIXADI is buprenorphine free base, a partial opioid agonist. BRIXADI is provided in multiple doses with two durations (weekly and monthly). : 1 BRIXADI (weekly; 8, 16, 24, 32 mg) consists of 50 mg/mL buprenorphine. The inactive ingredients include dehydrated alcohol (12% v/v), glycerol dioleate (43% v/v), and soybean phosphatidylcholine (41% w/v)., 2 BRIXADI (monthly; 64, 96, 128 mg) consists of 356 mg/mL buprenorphine. The inactive ingredients include glycerol dioleate (24% v/v), methylpyrrolidone (31% v/v), and soybean phosphatidylcholine (15% w/v).</Description>
</NDC>
<NDC>
<NDCCode>59651-224-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59651-224-01) </PackageDescription>
<NDC11Code>59651-0224-01</NDC11Code>
<ProductNDC>59651-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pilocarpine Hydrochloride</ProprietaryName>
<NonProprietaryName>Pilocarpine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190813</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212377</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PILOCARPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGEPilocarpine hydrochloride tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.</IndicationAndUsage>
<Description>DESCRIPTION. Pilocarpine hydrochloride tablets, USP contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a white or almost white, crystalline powder or colorless crystals, hygroscopic which is very soluble in water and freely soluble in ethanol (96 percent). Pilocarpine hydrochloride, with a chemical name of (3S-cis)-2(3H)-Furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl] monohydrochloride, has a molecular weight of 244.72. Each 5 mg pilocarpine hydrochloride tablet, USP for oral administration contains 5 mg of pilocarpine hydrochloride USP. Inactive ingredients in the tablet are: hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid and titanium dioxide. Each 7.5 mg pilocarpine hydrochloride tablet, USP for oral administration contains 7.5 mg of pilocarpine hydrochloride USP. Inactive ingredients in the tablet are: FD&C blue # 2, hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
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<PackageDescription>59 mL in 1 BOTTLE, SPRAY (75447-100-02) </PackageDescription>
<NDC11Code>75447-0100-02</NDC11Code>
<ProductNDC>75447-100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Optimal Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200609</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Optisource International Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75447-200-02</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (75447-200-02) </PackageDescription>
<NDC11Code>75447-0200-02</NDC11Code>
<ProductNDC>75447-200</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Optimal Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200609</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Optisource International Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75447-200-50</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, DISPENSING (75447-200-50) </PackageDescription>
<NDC11Code>75447-0200-50</NDC11Code>
<ProductNDC>75447-200</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Optimal Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200609</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Optisource International Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For hand sanitizing to decrease bacteria on the skin Recommended for repeat use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0054-0650-25</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0054-0650-25) </PackageDescription>
<NDC11Code>00054-0650-25</NDC11Code>
<ProductNDC>0054-0650</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, Caffeine And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, Caffeine And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215138</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>50; 300; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in two strength combinations in capsule form for oral administration. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/300 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….300 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….325 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, USP (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. MW = 224.26. Acetaminophen, USP (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MW = 151.16. Caffeine, USP (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:. C8H10N4O2. MW = 194.19. Codeine Phosphate, USP (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula. C18H21NO3H3PO41/2H2O. MW = 406.37. Inactive Ingredients: pregelatinized starch. colloidal silicon dioxide, magnesium stearate. The capsule cap is printed with white ink. The white ink contains shellac glaze, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone. The capsule body is printed with black ink. The black ink contains shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide. The capsule shell contains: gelatin, titanium dioxide for both strengths and FD&C red #40, FD&C blue #1 in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40mg/30mg and FD&C red #3, FD&C blue #2, red iron oxide, yellow iron oxide in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40mg/30mg.</Description>
</NDC>
<NDC>
<NDCCode>0054-3000-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0054-3000-01) </PackageDescription>
<NDC11Code>00054-3000-01</NDC11Code>
<ProductNDC>0054-3000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, Caffeine And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, Caffeine And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215138</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>50; 325; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in two strength combinations in capsule form for oral administration. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/300 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….300 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….325 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, USP (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. MW = 224.26. Acetaminophen, USP (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MW = 151.16. Caffeine, USP (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:. C8H10N4O2. MW = 194.19. Codeine Phosphate, USP (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula. C18H21NO3H3PO41/2H2O. MW = 406.37. Inactive Ingredients: pregelatinized starch. colloidal silicon dioxide, magnesium stearate. The capsule cap is printed with white ink. The white ink contains shellac glaze, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone. The capsule body is printed with black ink. The black ink contains shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide. The capsule shell contains: gelatin, titanium dioxide for both strengths and FD&C red #40, FD&C blue #1 in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40mg/30mg and FD&C red #3, FD&C blue #2, red iron oxide, yellow iron oxide in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40mg/30mg.</Description>
</NDC>
<NDC>
<NDCCode>0078-0630-35</NDCCode>
<PackageDescription>224 PACKAGE in 1 BOX, UNIT-DOSE (0078-0630-35) > 56 BLISTER PACK in 1 PACKAGE (0078-0630-56) > 4 CAPSULE in 1 BLISTER PACK (0078-0630-11) </PackageDescription>
<NDC11Code>00078-0630-35</NDC11Code>
<ProductNDC>0078-0630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobi Podhaler</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL; RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130322</StartMarketingDate>
<EndMarketingDate>20220731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201688</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>28</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130322</StartMarketingDatePackage>
<EndMarketingDatePackage>20220731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0143-9289-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0143-9289-01) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9289-01</NDC11Code>
<ProductNDC>0143-9289</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol Valerate</ProprietaryName>
<NonProprietaryName>Estradiol Valerate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20200421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203723</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ESTRADIOL VALERATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol Valerate Injection, USP is indicated in the: : 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause. , 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. , 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. , 4 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). .</IndicationAndUsage>
<Description>Estradiol Valerate Injection, USP contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg Estradiol Valerate, USP in a vehicle containing 5 mg Chlorobutanol, NF (chloral derivative/preservative) and 895 mg Sesame Oil, NF; 20 mg Estradiol Valerate, USP in a vehicle containing 224 mg Benzyl Benzoate, USP, 20 mg Benzyl Alcohol, NF (preservative), and 726 mg Castor Oil, USP; 40 mg Estradiol Valerate, USP in a vehicle containing 447 mg Benzyl Benzoate, USP, 20 mg Benzyl Alcohol, NF, and 533 mg Castor Oil, USP. Estradiol Valerate, USP is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula:. C23H32O3 MW 356.50.</Description>
</NDC>
<NDC>
<NDCCode>0143-9290-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0143-9290-01) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9290-01</NDC11Code>
<ProductNDC>0143-9290</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol Valerate</ProprietaryName>
<NonProprietaryName>Estradiol Valerate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20200421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203723</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ESTRADIOL VALERATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol Valerate Injection, USP is indicated in the: : 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause. , 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. , 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. , 4 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). .</IndicationAndUsage>
<Description>Estradiol Valerate Injection, USP contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg Estradiol Valerate, USP in a vehicle containing 5 mg Chlorobutanol, NF (chloral derivative/preservative) and 895 mg Sesame Oil, NF; 20 mg Estradiol Valerate, USP in a vehicle containing 224 mg Benzyl Benzoate, USP, 20 mg Benzyl Alcohol, NF (preservative), and 726 mg Castor Oil, USP; 40 mg Estradiol Valerate, USP in a vehicle containing 447 mg Benzyl Benzoate, USP, 20 mg Benzyl Alcohol, NF, and 533 mg Castor Oil, USP. Estradiol Valerate, USP is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula:. C23H32O3 MW 356.50.</Description>
</NDC>
<NDC>
<NDCCode>0143-9291-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0143-9291-01) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9291-01</NDC11Code>
<ProductNDC>0143-9291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol Valerate</ProprietaryName>
<NonProprietaryName>Estradiol Valerate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20200421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203723</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ESTRADIOL VALERATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol Valerate Injection, USP is indicated in the: : 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause. , 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. , 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. , 4 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). .</IndicationAndUsage>
<Description>Estradiol Valerate Injection, USP contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg Estradiol Valerate, USP in a vehicle containing 5 mg Chlorobutanol, NF (chloral derivative/preservative) and 895 mg Sesame Oil, NF; 20 mg Estradiol Valerate, USP in a vehicle containing 224 mg Benzyl Benzoate, USP, 20 mg Benzyl Alcohol, NF (preservative), and 726 mg Castor Oil, USP; 40 mg Estradiol Valerate, USP in a vehicle containing 447 mg Benzyl Benzoate, USP, 20 mg Benzyl Alcohol, NF, and 533 mg Castor Oil, USP. Estradiol Valerate, USP is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17β)-, 17-pentanoate. Graphic formula:. C23H32O3 MW 356.50.</Description>
</NDC>
<NDC>
<NDCCode>0338-0673-04</NDCCode>
<PackageDescription>1000 mL in 1 BAG (0338-0673-04) </PackageDescription>
<NDC11Code>00338-0673-04</NDC11Code>
<ProductNDC>0338-0673</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride In Dextrose And Sodium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride, Dextrose Monohydrate And Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19790202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018008</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>224; 5; 450</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19790202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Chloride in Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories.</IndicationAndUsage>
<Description>Potassium Chloride in Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Dextrose is derived from corn. The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-0685-04</NDCCode>
<PackageDescription>1000 mL in 1 BAG (0338-0685-04)</PackageDescription>
<NDC11Code>00338-0685-04</NDC11Code>
<ProductNDC>0338-0685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride In Dextrose</ProprietaryName>
<NonProprietaryName>Potassium Chloride And Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19790201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017634</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>5; 224</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-12-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>0404-9936-10</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (0404-9936-10) / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00404-9936-10</NDC11Code>
<ProductNDC>0404-9936</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088901</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>meq/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.</IndicationAndUsage>
<Description>Potassium Chloride for Injection Concentrate, USP is a sterile, nonpyrogenic concentrated solution of Potassium Chloride, USP in Water for Injection to be administered by intravenous infusion only after dilution in a larger volume of fluid. Each mL of Potassium Chloride for Injection Concentrate contains 2 mEq of K+ and Cl– equivalent to 149 mg of potassium chloride and has an osmolarity of 4000 mOsmol/L (calc). A more concentrated Potassium Chloride for Injection Concentrate is also available. Each mL of this injection contains 3 mEq of K+ and Cl– equivalent to 224 mg of potassium chloride and has an osmolarity of 6000 mOsmol/L(calc). pH (4.0-8.0) may have been adjusted with hydrochloric acid and if necessary, potassium hydroxide. Some packages are intended for multiple dose use and contain preservatives (0.05% methylparaben and 0.005% propylparaben). A summary of the available products is presented in the HOW SUPPLIED section. Potassium Chloride for Injection Concentrate (appropriately diluted) is a parenteral fluid and electrolyte replenisher.</Description>
</NDC>
<NDC>
<NDCCode>0404-9936-20</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (0404-9936-20) / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00404-9936-20</NDC11Code>
<ProductNDC>0404-9936</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088901</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>meq/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.</IndicationAndUsage>
<Description>Potassium Chloride for Injection Concentrate, USP is a sterile, nonpyrogenic concentrated solution of Potassium Chloride, USP in Water for Injection to be administered by intravenous infusion only after dilution in a larger volume of fluid. Each mL of Potassium Chloride for Injection Concentrate contains 2 mEq of K+ and Cl– equivalent to 149 mg of potassium chloride and has an osmolarity of 4000 mOsmol/L (calc). A more concentrated Potassium Chloride for Injection Concentrate is also available. Each mL of this injection contains 3 mEq of K+ and Cl– equivalent to 224 mg of potassium chloride and has an osmolarity of 6000 mOsmol/L(calc). pH (4.0-8.0) may have been adjusted with hydrochloric acid and if necessary, potassium hydroxide. Some packages are intended for multiple dose use and contain preservatives (0.05% methylparaben and 0.005% propylparaben). A summary of the available products is presented in the HOW SUPPLIED section. Potassium Chloride for Injection Concentrate (appropriately diluted) is a parenteral fluid and electrolyte replenisher.</Description>
</NDC>
<NDC>
<NDCCode>0409-0032-01</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-0032-01) / 15 mL in 1 VIAL, SINGLE-DOSE (0409-0032-10) </PackageDescription>
<NDC11Code>00409-0032-01</NDC11Code>
<ProductNDC>0409-0032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217459</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Phosphates Injection is indicated as a source of phosphorus: : 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. , 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. .</IndicationAndUsage>
<Description>Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as 15 mL single-dose vials. Monobasic Potassium Phosphate is chemically designated KH2PO4, molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K2HPO4, molecular weight 174.18, colorless or white granular salt freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>0409-7295-01</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-7295-01) / 15 mL in 1 VIAL, SINGLE-DOSE (0409-7295-11) </PackageDescription>
<NDC11Code>00409-7295-01</NDC11Code>
<ProductNDC>0409-7295</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphate, Monobasic And Potassium Phosphate, Dibasic</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050826</StartMarketingDate>
<EndMarketingDate>20260201</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DIBASIC POTASSIUM PHOSPHATE; MONOBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>236; 224</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050826</StartMarketingDatePackage>
<EndMarketingDatePackage>20260201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of potassium (K+ 4.4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions. Safety has not been established for parenteral nutrition in pediatric patients due to the risk of aluminum toxicity. (See WARNINGS).</IndicationAndUsage>
<Description>Potassium Phosphates Injection, USP 3 mM P/mL (millimoles/mL) is a sterile, nonpyrogenic, concentrated solution containing a mixture of mono- and dibasic potassium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each milliliter contains 224 mg of monobasic potassium phosphate, anhydrous and 236 mg of dibasic potassium phosphate, anhydrous. One mM of phosphorus weighs 31 mg and the product provides 93 mg (approximately 3 mM) of phosphorus/mL, plus 170.3 mg (4.4 mEq) of potassium/mL. Note: 1 mM P=1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The osmolar concentration is 7.4 mOsmol/mL (calc.). The solution is intended as an alternative to sodium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. Monobasic Potassium Phosphate, NF (monopotassium phosphate), anhydrous is chemically designated KH2PO4, colorless crystals or white granular powder freely soluble in water. Dibasic Potassium Phosphate, USP (dipotassium phosphate), anhydrous is chemically designated K2HPO4, white granules very soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>0409-7295-17</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-7295-17) > 15 mL in 1 VIAL, SINGLE-DOSE (0409-7295-27)</PackageDescription>
<NDC11Code>00409-7295-17</NDC11Code>
<ProductNDC>0409-7295</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphate, Monobasic And Potassium Phosphate, Dibasic</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-08-23</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-7996-09</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-7996-09) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-7996-09</NDC11Code>
<ProductNDC>0409-7996</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride In Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19800529</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018371</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>5; .224</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19800529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0517-0420-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0517-0420-01) / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00517-0420-01</NDC11Code>
<ProductNDC>0517-0420</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol Valerate</ProprietaryName>
<NonProprietaryName>Estradiol Valerate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090920</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>ESTRADIOL VALERATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol Valerate Injection is indicated in the. 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).</IndicationAndUsage>
<Description>Estradiol Valerate Injection, USP contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to yellow. Formulations (per mL): 20 mg estradiol valerate in a vehicle containing 224 mg benzyl benzoate, 20 mg benzyl alcohol (preservative), and castor oil; 40 mg estradiol valerate in a vehicle containing 447 mg benzyl benzoate, 20 mg benzyl alcohol, and castor oil. Estradiol valerate is designated chemically as estra-1,3,5(10) – triene-3, 17 – diol(17 β) - , 17-pentanoate. Graphic formula. C23H32O3 MW 356.50.</Description>
</NDC>
</NDCList>