{
"NDC": [
{
"NDCCode": "66336-442-24",
"PackageDescription": "24 TABLET in 1 BOTTLE, PLASTIC (66336-442-24)",
"NDC11Code": "66336-0442-24",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-059-24",
"PackageDescription": "24 TABLET in 1 BOTTLE (66336-059-24)",
"NDC11Code": "66336-0059-24",
"ProductNDC": "66336-059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089805",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "CODEINE PHOSPHATE; ACETAMINOPHEN",
"StrengthNumber": "30; 300",
"StrengthUnit": "mg/1; mg/1",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.",
"Description": "Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each 300 mg/30 mg Acetaminophen and Codeine Phosphate Tablet contains: Acetaminophen ......................................................................................................300 mg Codeine Phosphate ..................................................................................................30 mg. Each 300 mg/60 mg Acetaminophen and Codeine Phosphate Tablet contains: Acetaminophen ......................................................................................................300 mg Codeine Phosphate ..................................................................................................60 mg."
},
{
"NDCCode": "66336-147-24",
"PackageDescription": "24 TABLET in 1 BOTTLE (66336-147-24)",
"NDC11Code": "66336-0147-24",
"ProductNDC": "66336-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110308",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040545",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg*, 2 Acetaminophen USP ........................................................................................325 mg, 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone."
},
{
"NDCCode": "66336-670-24",
"PackageDescription": "24 TABLET in 1 BOTTLE (66336-670-24)",
"NDC11Code": "66336-0670-24",
"ProductNDC": "66336-670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040655",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "36800-442-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (36800-442-24) > 12 TABLET in 1 BLISTER PACK",
"NDC11Code": "36800-0442-24",
"ProductNDC": "36800-442",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Tab Tussin",
"ProprietaryNameSuffix": "Dm",
"NonProprietaryName": "Dextromethorphan Hydrobromide / Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210506",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "TOPCO ASSOCIATES LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 400",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210506",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus. helps make coughs more productive."
},
{
"NDCCode": "60687-442-75",
"PackageDescription": "4 TRAY in 1 CASE (60687-442-75) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-442-53) / 20 mL in 1 CUP, UNIT-DOSE (60687-442-24) ",
"NDC11Code": "60687-0442-75",
"ProductNDC": "60687-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20241107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091348",
"LabelerName": "American Health Packaging",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "200; 40",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241107",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim oral suspension in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim oral suspension could offer some advantage over the use of a single antimicrobial agent. Shigellosis For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler’s Diarrhea in Adults For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim oral suspension, USP is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim in each teaspoonful (5 mL). Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula:. Each teaspoonful (5 mL) of the oral suspension contains 200 mg sulfamethoxazole and 40 mg trimethoprim as well as the following inactive ingredients: alcohol 0.04% (v/v), carboxymethylcellulose sodium, citric acid anhydrous, colloidal silicon dioxide, FD&C Red #40, flavour cherry #557, glycerin, methyl paraben, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, saccharin sodium, sodium benzoate, and sorbitol solution."
},
{
"NDCCode": "69842-442-24",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (69842-442-24) / 1 KIT in 1 BLISTER PACK * 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69842-617-16) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69842-290-08) ",
"NDC11Code": "69842-0442-24",
"ProductNDC": "69842-442",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Strength Daytime Nighttime Sinus Relief",
"NonProprietaryName": "Acetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl And Acetaminophen Dextromethorphan Hbr Doxylamine Succinate Phenylephrine Hcl",
"DosageFormName": "KIT",
"StartMarketingDate": "20210710",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "CVS Pharmacy, Inc.",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210710",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves:."
},
{
"NDCCode": "66336-442-06",
"PackageDescription": "6 TABLET in 1 BOTTLE, PLASTIC (66336-442-06)",
"NDC11Code": "66336-0442-06",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-442-10",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (66336-442-10)",
"NDC11Code": "66336-0442-10",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-442-12",
"PackageDescription": "12 TABLET in 1 BOTTLE, PLASTIC (66336-442-12)",
"NDC11Code": "66336-0442-12",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-442-14",
"PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (66336-442-14)",
"NDC11Code": "66336-0442-14",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-442-15",
"PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (66336-442-15)",
"NDC11Code": "66336-0442-15",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-442-16",
"PackageDescription": "16 TABLET in 1 BOTTLE, PLASTIC (66336-442-16)",
"NDC11Code": "66336-0442-16",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-442-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (66336-442-20)",
"NDC11Code": "66336-0442-20",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-442-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (66336-442-30)",
"NDC11Code": "66336-0442-30",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-442-40",
"PackageDescription": "40 TABLET in 1 BOTTLE, PLASTIC (66336-442-40)",
"NDC11Code": "66336-0442-40",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-442-44",
"PackageDescription": "4 TABLET in 1 BOTTLE, PLASTIC (66336-442-44)",
"NDC11Code": "66336-0442-44",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-442-45",
"PackageDescription": "45 TABLET in 1 BOTTLE, PLASTIC (66336-442-45)",
"NDC11Code": "66336-0442-45",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-442-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (66336-442-60)",
"NDC11Code": "66336-0442-60",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-442-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (66336-442-90)",
"NDC11Code": "66336-0442-90",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-442-94",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (66336-442-94)",
"NDC11Code": "66336-0442-94",
"ProductNDC": "66336-442",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19881202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089971",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "66336-063-15",
"PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (66336-063-15)",
"NDC11Code": "66336-0063-15",
"ProductNDC": "66336-063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040489",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets, USP, 500 mg and 750 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains either 500 mg or 750 mg of methocarbamol, USP. The inactive ingredients present are colloidal silicon dioxide, magnesium stearate, povidone, pregelatinized corn starch, purified water, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "66336-063-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (66336-063-30)",
"NDC11Code": "66336-0063-30",
"ProductNDC": "66336-063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040489",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets, USP, 500 mg and 750 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains either 500 mg or 750 mg of methocarbamol, USP. The inactive ingredients present are colloidal silicon dioxide, magnesium stearate, povidone, pregelatinized corn starch, purified water, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "66336-063-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (66336-063-60)",
"NDC11Code": "66336-0063-60",
"ProductNDC": "66336-063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040489",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets, USP, 500 mg and 750 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains either 500 mg or 750 mg of methocarbamol, USP. The inactive ingredients present are colloidal silicon dioxide, magnesium stearate, povidone, pregelatinized corn starch, purified water, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "66336-080-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (66336-080-30)",
"NDC11Code": "66336-0080-30",
"ProductNDC": "66336-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20000101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085159",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is. The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains 500 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate."
},
{
"NDCCode": "66336-185-07",
"PackageDescription": "7 CAPSULE in 1 BOTTLE (66336-185-07)",
"NDC11Code": "66336-0185-07",
"ProductNDC": "66336-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040875",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.",
"Description": "Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. (KVK TECH INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: a) powder-filled capsules containing 15 mg of phentermine hydrochloride(equivalent to 12mg of phentermine) or 30 mg phentermine hydrochloride ( equivalent to 24mg phentermine) and inactive ingredients. Corn starch, gelatin, magnesium stearate, lactose monohydrate. In addition, the 15mg capsules contain D and C Yellow #10, FD and C Blue #1, FD and C Red #3, FD and C Red #40, titanium dioxide and the 30mg capsules contain D and C Yellow #10, FD and C RED #3, titanium dioxide. b) bead-filled capsules containing 30mg phentermine hydrochloride (equivalent to 24mg phentermine) and inactive ingredients. Corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD and C Blue #1-Brilliant blue FCF aluminum lake, D and C Red # 28 and gelatin. (LANNETT COMPANY, INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: powder-filled capsules containing 30 mg of phentermine hydrochloride (equivalent to 24 mg of phentermine base) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D and C Red # 28, and FD and C Blue # 1; the yellow/yellow capsules contain gelatin, D and C Yellow # 10, FD and C Red # 3, and titanium dioxide; the black/black capsules contain gelatin, FD and C Yellow # 6, FD and C Blue # 1, and FD and C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, FD and C Blue # 2 Aluminum Lake, FD and C Red # 40 Aluminum Lake, FD and C Blue # 1 Aluminum Lake, and D and C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. (MUTUAL Phamaceutical manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD and C Blue #2, FD and C Red #40, FD and C Blue #1 and D and C Yellow #10 Lake."
},
{
"NDCCode": "66336-185-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (66336-185-14)",
"NDC11Code": "66336-0185-14",
"ProductNDC": "66336-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040875",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.",
"Description": "Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. (KVK TECH INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: a) powder-filled capsules containing 15 mg of phentermine hydrochloride(equivalent to 12mg of phentermine) or 30 mg phentermine hydrochloride ( equivalent to 24mg phentermine) and inactive ingredients. Corn starch, gelatin, magnesium stearate, lactose monohydrate. In addition, the 15mg capsules contain D and C Yellow #10, FD and C Blue #1, FD and C Red #3, FD and C Red #40, titanium dioxide and the 30mg capsules contain D and C Yellow #10, FD and C RED #3, titanium dioxide. b) bead-filled capsules containing 30mg phentermine hydrochloride (equivalent to 24mg phentermine) and inactive ingredients. Corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD and C Blue #1-Brilliant blue FCF aluminum lake, D and C Red # 28 and gelatin. (LANNETT COMPANY, INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: powder-filled capsules containing 30 mg of phentermine hydrochloride (equivalent to 24 mg of phentermine base) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D and C Red # 28, and FD and C Blue # 1; the yellow/yellow capsules contain gelatin, D and C Yellow # 10, FD and C Red # 3, and titanium dioxide; the black/black capsules contain gelatin, FD and C Yellow # 6, FD and C Blue # 1, and FD and C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, FD and C Blue # 2 Aluminum Lake, FD and C Red # 40 Aluminum Lake, FD and C Blue # 1 Aluminum Lake, and D and C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. (MUTUAL Phamaceutical manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD and C Blue #2, FD and C Red #40, FD and C Blue #1 and D and C Yellow #10 Lake."
},
{
"NDCCode": "66336-185-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (66336-185-21)",
"NDC11Code": "66336-0185-21",
"ProductNDC": "66336-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040875",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.",
"Description": "Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. (KVK TECH INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: a) powder-filled capsules containing 15 mg of phentermine hydrochloride(equivalent to 12mg of phentermine) or 30 mg phentermine hydrochloride ( equivalent to 24mg phentermine) and inactive ingredients. Corn starch, gelatin, magnesium stearate, lactose monohydrate. In addition, the 15mg capsules contain D and C Yellow #10, FD and C Blue #1, FD and C Red #3, FD and C Red #40, titanium dioxide and the 30mg capsules contain D and C Yellow #10, FD and C RED #3, titanium dioxide. b) bead-filled capsules containing 30mg phentermine hydrochloride (equivalent to 24mg phentermine) and inactive ingredients. Corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD and C Blue #1-Brilliant blue FCF aluminum lake, D and C Red # 28 and gelatin. (LANNETT COMPANY, INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: powder-filled capsules containing 30 mg of phentermine hydrochloride (equivalent to 24 mg of phentermine base) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D and C Red # 28, and FD and C Blue # 1; the yellow/yellow capsules contain gelatin, D and C Yellow # 10, FD and C Red # 3, and titanium dioxide; the black/black capsules contain gelatin, FD and C Yellow # 6, FD and C Blue # 1, and FD and C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, FD and C Blue # 2 Aluminum Lake, FD and C Red # 40 Aluminum Lake, FD and C Blue # 1 Aluminum Lake, and D and C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. (MUTUAL Phamaceutical manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD and C Blue #2, FD and C Red #40, FD and C Blue #1 and D and C Yellow #10 Lake."
},
{
"NDCCode": "66336-185-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (66336-185-28)",
"NDC11Code": "66336-0185-28",
"ProductNDC": "66336-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040875",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.",
"Description": "Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. (KVK TECH INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: a) powder-filled capsules containing 15 mg of phentermine hydrochloride(equivalent to 12mg of phentermine) or 30 mg phentermine hydrochloride ( equivalent to 24mg phentermine) and inactive ingredients. Corn starch, gelatin, magnesium stearate, lactose monohydrate. In addition, the 15mg capsules contain D and C Yellow #10, FD and C Blue #1, FD and C Red #3, FD and C Red #40, titanium dioxide and the 30mg capsules contain D and C Yellow #10, FD and C RED #3, titanium dioxide. b) bead-filled capsules containing 30mg phentermine hydrochloride (equivalent to 24mg phentermine) and inactive ingredients. Corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD and C Blue #1-Brilliant blue FCF aluminum lake, D and C Red # 28 and gelatin. (LANNETT COMPANY, INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: powder-filled capsules containing 30 mg of phentermine hydrochloride (equivalent to 24 mg of phentermine base) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D and C Red # 28, and FD and C Blue # 1; the yellow/yellow capsules contain gelatin, D and C Yellow # 10, FD and C Red # 3, and titanium dioxide; the black/black capsules contain gelatin, FD and C Yellow # 6, FD and C Blue # 1, and FD and C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, FD and C Blue # 2 Aluminum Lake, FD and C Red # 40 Aluminum Lake, FD and C Blue # 1 Aluminum Lake, and D and C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. (MUTUAL Phamaceutical manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD and C Blue #2, FD and C Red #40, FD and C Blue #1 and D and C Yellow #10 Lake."
},
{
"NDCCode": "66336-185-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (66336-185-30)",
"NDC11Code": "66336-0185-30",
"ProductNDC": "66336-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040875",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.",
"Description": "Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. (KVK TECH INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: a) powder-filled capsules containing 15 mg of phentermine hydrochloride(equivalent to 12mg of phentermine) or 30 mg phentermine hydrochloride ( equivalent to 24mg phentermine) and inactive ingredients. Corn starch, gelatin, magnesium stearate, lactose monohydrate. In addition, the 15mg capsules contain D and C Yellow #10, FD and C Blue #1, FD and C Red #3, FD and C Red #40, titanium dioxide and the 30mg capsules contain D and C Yellow #10, FD and C RED #3, titanium dioxide. b) bead-filled capsules containing 30mg phentermine hydrochloride (equivalent to 24mg phentermine) and inactive ingredients. Corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD and C Blue #1-Brilliant blue FCF aluminum lake, D and C Red # 28 and gelatin. (LANNETT COMPANY, INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: powder-filled capsules containing 30 mg of phentermine hydrochloride (equivalent to 24 mg of phentermine base) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D and C Red # 28, and FD and C Blue # 1; the yellow/yellow capsules contain gelatin, D and C Yellow # 10, FD and C Red # 3, and titanium dioxide; the black/black capsules contain gelatin, FD and C Yellow # 6, FD and C Blue # 1, and FD and C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, FD and C Blue # 2 Aluminum Lake, FD and C Red # 40 Aluminum Lake, FD and C Blue # 1 Aluminum Lake, and D and C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. (MUTUAL Phamaceutical manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD and C Blue #2, FD and C Red #40, FD and C Blue #1 and D and C Yellow #10 Lake."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>66336-442-24</NDCCode>
<PackageDescription>24 TABLET in 1 BOTTLE, PLASTIC (66336-442-24)</PackageDescription>
<NDC11Code>66336-0442-24</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-059-24</NDCCode>
<PackageDescription>24 TABLET in 1 BOTTLE (66336-059-24)</PackageDescription>
<NDC11Code>66336-0059-24</NDC11Code>
<ProductNDC>66336-059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089805</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>30; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.</IndicationAndUsage>
<Description>Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each 300 mg/30 mg Acetaminophen and Codeine Phosphate Tablet contains: Acetaminophen ......................................................................................................300 mg Codeine Phosphate ..................................................................................................30 mg. Each 300 mg/60 mg Acetaminophen and Codeine Phosphate Tablet contains: Acetaminophen ......................................................................................................300 mg Codeine Phosphate ..................................................................................................60 mg.</Description>
</NDC>
<NDC>
<NDCCode>66336-147-24</NDCCode>
<PackageDescription>24 TABLET in 1 BOTTLE (66336-147-24)</PackageDescription>
<NDC11Code>66336-0147-24</NDC11Code>
<ProductNDC>66336-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110308</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040545</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone and acetaminophen tablets USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: 1 Oxycodone Hydrochloride USP ..........................................................................5 mg*, 2 Acetaminophen USP ........................................................................................325 mg, 3 *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.</Description>
</NDC>
<NDC>
<NDCCode>66336-670-24</NDCCode>
<PackageDescription>24 TABLET in 1 BOTTLE (66336-670-24)</PackageDescription>
<NDC11Code>66336-0670-24</NDC11Code>
<ProductNDC>66336-670</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040655</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-442-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (36800-442-24) > 12 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>36800-0442-24</NDC11Code>
<ProductNDC>36800-442</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Tab Tussin</ProprietaryName>
<ProprietaryNameSuffix>Dm</ProprietaryNameSuffix>
<NonProprietaryName>Dextromethorphan Hydrobromide / Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210506</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>TOPCO ASSOCIATES LLC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 400</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus. helps make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60687-442-75</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (60687-442-75) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-442-53) / 20 mL in 1 CUP, UNIT-DOSE (60687-442-24) </PackageDescription>
<NDC11Code>60687-0442-75</NDC11Code>
<ProductNDC>60687-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091348</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>200; 40</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim oral suspension in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim oral suspension could offer some advantage over the use of a single antimicrobial agent. Shigellosis For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler’s Diarrhea in Adults For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim oral suspension, USP is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim in each teaspoonful (5 mL). Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula:. Each teaspoonful (5 mL) of the oral suspension contains 200 mg sulfamethoxazole and 40 mg trimethoprim as well as the following inactive ingredients: alcohol 0.04% (v/v), carboxymethylcellulose sodium, citric acid anhydrous, colloidal silicon dioxide, FD&C Red #40, flavour cherry #557, glycerin, methyl paraben, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, saccharin sodium, sodium benzoate, and sorbitol solution.</Description>
</NDC>
<NDC>
<NDCCode>69842-442-24</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (69842-442-24) / 1 KIT in 1 BLISTER PACK * 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69842-617-16) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69842-290-08) </PackageDescription>
<NDC11Code>69842-0442-24</NDC11Code>
<ProductNDC>69842-442</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maximum Strength Daytime Nighttime Sinus Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl And Acetaminophen Dextromethorphan Hbr Doxylamine Succinate Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210710</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>CVS Pharmacy, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves:.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-06</NDCCode>
<PackageDescription>6 TABLET in 1 BOTTLE, PLASTIC (66336-442-06)</PackageDescription>
<NDC11Code>66336-0442-06</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (66336-442-10)</PackageDescription>
<NDC11Code>66336-0442-10</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE, PLASTIC (66336-442-12)</PackageDescription>
<NDC11Code>66336-0442-12</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE, PLASTIC (66336-442-14)</PackageDescription>
<NDC11Code>66336-0442-14</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (66336-442-15)</PackageDescription>
<NDC11Code>66336-0442-15</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-16</NDCCode>
<PackageDescription>16 TABLET in 1 BOTTLE, PLASTIC (66336-442-16)</PackageDescription>
<NDC11Code>66336-0442-16</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (66336-442-20)</PackageDescription>
<NDC11Code>66336-0442-20</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (66336-442-30)</PackageDescription>
<NDC11Code>66336-0442-30</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE, PLASTIC (66336-442-40)</PackageDescription>
<NDC11Code>66336-0442-40</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-44</NDCCode>
<PackageDescription>4 TABLET in 1 BOTTLE, PLASTIC (66336-442-44)</PackageDescription>
<NDC11Code>66336-0442-44</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-45</NDCCode>
<PackageDescription>45 TABLET in 1 BOTTLE, PLASTIC (66336-442-45)</PackageDescription>
<NDC11Code>66336-0442-45</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (66336-442-60)</PackageDescription>
<NDC11Code>66336-0442-60</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (66336-442-90)</PackageDescription>
<NDC11Code>66336-0442-90</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-442-94</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (66336-442-94)</PackageDescription>
<NDC11Code>66336-0442-94</NDC11Code>
<ProductNDC>66336-442</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089971</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66336-063-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (66336-063-15)</PackageDescription>
<NDC11Code>66336-0063-15</NDC11Code>
<ProductNDC>66336-063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040489</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets, USP, 500 mg and 750 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains either 500 mg or 750 mg of methocarbamol, USP. The inactive ingredients present are colloidal silicon dioxide, magnesium stearate, povidone, pregelatinized corn starch, purified water, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>66336-063-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (66336-063-30)</PackageDescription>
<NDC11Code>66336-0063-30</NDC11Code>
<ProductNDC>66336-063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040489</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets, USP, 500 mg and 750 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains either 500 mg or 750 mg of methocarbamol, USP. The inactive ingredients present are colloidal silicon dioxide, magnesium stearate, povidone, pregelatinized corn starch, purified water, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>66336-063-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (66336-063-60)</PackageDescription>
<NDC11Code>66336-0063-60</NDC11Code>
<ProductNDC>66336-063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040489</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets, USP, 500 mg and 750 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains either 500 mg or 750 mg of methocarbamol, USP. The inactive ingredients present are colloidal silicon dioxide, magnesium stearate, povidone, pregelatinized corn starch, purified water, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>66336-080-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (66336-080-30)</PackageDescription>
<NDC11Code>66336-0080-30</NDC11Code>
<ProductNDC>66336-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085159</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is. The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains 500 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate.</Description>
</NDC>
<NDC>
<NDCCode>66336-185-07</NDCCode>
<PackageDescription>7 CAPSULE in 1 BOTTLE (66336-185-07)</PackageDescription>
<NDC11Code>66336-0185-07</NDC11Code>
<ProductNDC>66336-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040875</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. (KVK TECH INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: a) powder-filled capsules containing 15 mg of phentermine hydrochloride(equivalent to 12mg of phentermine) or 30 mg phentermine hydrochloride ( equivalent to 24mg phentermine) and inactive ingredients. Corn starch, gelatin, magnesium stearate, lactose monohydrate. In addition, the 15mg capsules contain D and C Yellow #10, FD and C Blue #1, FD and C Red #3, FD and C Red #40, titanium dioxide and the 30mg capsules contain D and C Yellow #10, FD and C RED #3, titanium dioxide. b) bead-filled capsules containing 30mg phentermine hydrochloride (equivalent to 24mg phentermine) and inactive ingredients. Corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD and C Blue #1-Brilliant blue FCF aluminum lake, D and C Red # 28 and gelatin. (LANNETT COMPANY, INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: powder-filled capsules containing 30 mg of phentermine hydrochloride (equivalent to 24 mg of phentermine base) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D and C Red # 28, and FD and C Blue # 1; the yellow/yellow capsules contain gelatin, D and C Yellow # 10, FD and C Red # 3, and titanium dioxide; the black/black capsules contain gelatin, FD and C Yellow # 6, FD and C Blue # 1, and FD and C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, FD and C Blue # 2 Aluminum Lake, FD and C Red # 40 Aluminum Lake, FD and C Blue # 1 Aluminum Lake, and D and C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. (MUTUAL Phamaceutical manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD and C Blue #2, FD and C Red #40, FD and C Blue #1 and D and C Yellow #10 Lake.</Description>
</NDC>
<NDC>
<NDCCode>66336-185-14</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (66336-185-14)</PackageDescription>
<NDC11Code>66336-0185-14</NDC11Code>
<ProductNDC>66336-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040875</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. (KVK TECH INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: a) powder-filled capsules containing 15 mg of phentermine hydrochloride(equivalent to 12mg of phentermine) or 30 mg phentermine hydrochloride ( equivalent to 24mg phentermine) and inactive ingredients. Corn starch, gelatin, magnesium stearate, lactose monohydrate. In addition, the 15mg capsules contain D and C Yellow #10, FD and C Blue #1, FD and C Red #3, FD and C Red #40, titanium dioxide and the 30mg capsules contain D and C Yellow #10, FD and C RED #3, titanium dioxide. b) bead-filled capsules containing 30mg phentermine hydrochloride (equivalent to 24mg phentermine) and inactive ingredients. Corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD and C Blue #1-Brilliant blue FCF aluminum lake, D and C Red # 28 and gelatin. (LANNETT COMPANY, INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: powder-filled capsules containing 30 mg of phentermine hydrochloride (equivalent to 24 mg of phentermine base) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D and C Red # 28, and FD and C Blue # 1; the yellow/yellow capsules contain gelatin, D and C Yellow # 10, FD and C Red # 3, and titanium dioxide; the black/black capsules contain gelatin, FD and C Yellow # 6, FD and C Blue # 1, and FD and C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, FD and C Blue # 2 Aluminum Lake, FD and C Red # 40 Aluminum Lake, FD and C Blue # 1 Aluminum Lake, and D and C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. (MUTUAL Phamaceutical manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD and C Blue #2, FD and C Red #40, FD and C Blue #1 and D and C Yellow #10 Lake.</Description>
</NDC>
<NDC>
<NDCCode>66336-185-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (66336-185-21)</PackageDescription>
<NDC11Code>66336-0185-21</NDC11Code>
<ProductNDC>66336-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040875</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. (KVK TECH INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: a) powder-filled capsules containing 15 mg of phentermine hydrochloride(equivalent to 12mg of phentermine) or 30 mg phentermine hydrochloride ( equivalent to 24mg phentermine) and inactive ingredients. Corn starch, gelatin, magnesium stearate, lactose monohydrate. In addition, the 15mg capsules contain D and C Yellow #10, FD and C Blue #1, FD and C Red #3, FD and C Red #40, titanium dioxide and the 30mg capsules contain D and C Yellow #10, FD and C RED #3, titanium dioxide. b) bead-filled capsules containing 30mg phentermine hydrochloride (equivalent to 24mg phentermine) and inactive ingredients. Corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD and C Blue #1-Brilliant blue FCF aluminum lake, D and C Red # 28 and gelatin. (LANNETT COMPANY, INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: powder-filled capsules containing 30 mg of phentermine hydrochloride (equivalent to 24 mg of phentermine base) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D and C Red # 28, and FD and C Blue # 1; the yellow/yellow capsules contain gelatin, D and C Yellow # 10, FD and C Red # 3, and titanium dioxide; the black/black capsules contain gelatin, FD and C Yellow # 6, FD and C Blue # 1, and FD and C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, FD and C Blue # 2 Aluminum Lake, FD and C Red # 40 Aluminum Lake, FD and C Blue # 1 Aluminum Lake, and D and C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. (MUTUAL Phamaceutical manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD and C Blue #2, FD and C Red #40, FD and C Blue #1 and D and C Yellow #10 Lake.</Description>
</NDC>
<NDC>
<NDCCode>66336-185-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (66336-185-28)</PackageDescription>
<NDC11Code>66336-0185-28</NDC11Code>
<ProductNDC>66336-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040875</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. (KVK TECH INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: a) powder-filled capsules containing 15 mg of phentermine hydrochloride(equivalent to 12mg of phentermine) or 30 mg phentermine hydrochloride ( equivalent to 24mg phentermine) and inactive ingredients. Corn starch, gelatin, magnesium stearate, lactose monohydrate. In addition, the 15mg capsules contain D and C Yellow #10, FD and C Blue #1, FD and C Red #3, FD and C Red #40, titanium dioxide and the 30mg capsules contain D and C Yellow #10, FD and C RED #3, titanium dioxide. b) bead-filled capsules containing 30mg phentermine hydrochloride (equivalent to 24mg phentermine) and inactive ingredients. Corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD and C Blue #1-Brilliant blue FCF aluminum lake, D and C Red # 28 and gelatin. (LANNETT COMPANY, INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: powder-filled capsules containing 30 mg of phentermine hydrochloride (equivalent to 24 mg of phentermine base) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D and C Red # 28, and FD and C Blue # 1; the yellow/yellow capsules contain gelatin, D and C Yellow # 10, FD and C Red # 3, and titanium dioxide; the black/black capsules contain gelatin, FD and C Yellow # 6, FD and C Blue # 1, and FD and C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, FD and C Blue # 2 Aluminum Lake, FD and C Red # 40 Aluminum Lake, FD and C Blue # 1 Aluminum Lake, and D and C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. (MUTUAL Phamaceutical manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD and C Blue #2, FD and C Red #40, FD and C Blue #1 and D and C Yellow #10 Lake.</Description>
</NDC>
<NDC>
<NDCCode>66336-185-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (66336-185-30)</PackageDescription>
<NDC11Code>66336-0185-30</NDC11Code>
<ProductNDC>66336-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040875</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. (KVK TECH INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: a) powder-filled capsules containing 15 mg of phentermine hydrochloride(equivalent to 12mg of phentermine) or 30 mg phentermine hydrochloride ( equivalent to 24mg phentermine) and inactive ingredients. Corn starch, gelatin, magnesium stearate, lactose monohydrate. In addition, the 15mg capsules contain D and C Yellow #10, FD and C Blue #1, FD and C Red #3, FD and C Red #40, titanium dioxide and the 30mg capsules contain D and C Yellow #10, FD and C RED #3, titanium dioxide. b) bead-filled capsules containing 30mg phentermine hydrochloride (equivalent to 24mg phentermine) and inactive ingredients. Corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD and C Blue #1-Brilliant blue FCF aluminum lake, D and C Red # 28 and gelatin. (LANNETT COMPANY, INC. manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as: powder-filled capsules containing 30 mg of phentermine hydrochloride (equivalent to 24 mg of phentermine base) and inactive ingredients: corn starch, magnesium stearate, lactose anhydrous. In addition, the natural/blue capsules contain gelatin, D and C Red # 28, and FD and C Blue # 1; the yellow/yellow capsules contain gelatin, D and C Yellow # 10, FD and C Red # 3, and titanium dioxide; the black/black capsules contain gelatin, FD and C Yellow # 6, FD and C Blue # 1, and FD and C Red # 40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, FD and C Blue # 2 Aluminum Lake, FD and C Red # 40 Aluminum Lake, FD and C Blue # 1 Aluminum Lake, and D and C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. (MUTUAL Phamaceutical manufacture). Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD and C Blue #2, FD and C Red #40, FD and C Blue #1 and D and C Yellow #10 Lake.</Description>
</NDC>
</NDCList>