{
"NDC": [
{
"NDCCode": "83119-241-51",
"PackageDescription": "1 JAR in 1 POUCH (83119-241-51) / 13 g in 1 JAR",
"NDC11Code": "83119-0241-51",
"ProductNDC": "83119-241",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unid Sun Cushion Baby And Kid",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251210",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Sage Pharmaceuticals Inc",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "9.72; 9.5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251210",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "83119-241-50",
"PackageDescription": "1 JAR in 1 BOX (83119-241-50) / 13 g in 1 JAR",
"NDC11Code": "83119-0241-50",
"ProductNDC": "83119-241",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unid Sun Cushion Baby And Kid",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251210",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Sage Pharmaceuticals Inc",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "9.72; 9.5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251210",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "83119-242-51",
"PackageDescription": "1 JAR in 1 POUCH (83119-242-51) / 13 g in 1 JAR",
"NDC11Code": "83119-0242-51",
"ProductNDC": "83119-242",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sun Cushion Baby And Kid",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251204",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Sage Pharmaceuticals Inc",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "9.72; 9.5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251204",
"SamplePackage": "N"
},
{
"NDCCode": "83119-245-51",
"PackageDescription": "1 BOTTLE in 1 BOX (83119-245-51) / 5 g in 1 BOTTLE",
"NDC11Code": "83119-0245-51",
"ProductNDC": "83119-245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unid Sea Fennel Tinted Sun Protector",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251218",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Sage Pharmaceuticals Inc",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "8.28",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251218",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "35000-241-43",
"PackageDescription": "51 g in 1 CONTAINER (35000-241-43) ",
"NDC11Code": "35000-0241-43",
"ProductNDC": "35000-241",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mens Speed Irish Spring Original - Ap And Deo",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240710",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "COLGATE PALMOLIVE COMPANY",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "159",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240710",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness. 24 hour protection."
},
{
"NDCCode": "81033-241-51",
"PackageDescription": "100 CUP, UNIT-DOSE in 1 CASE (81033-241-51) / 30 mL in 1 CUP, UNIT-DOSE (81033-241-30) ",
"NDC11Code": "81033-0241-51",
"ProductNDC": "81033-241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose Solution",
"NonProprietaryName": "Lactulose Solution Usp, 10 G/15 Ml",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20210416",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076645",
"LabelerName": "Kesin Pharma Corporation",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240416",
"SamplePackage": "N",
"IndicationAndUsage": "For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia level by 25 to 50%; this is generally paralleled by an improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed. in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients’ protein tolerance is also frequently observed with lactulose solution therapy. In the treatment of chronic portal systemic encephalopathy, lactulose solution has been given for over 2 years in controlled studies.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15mL contains: Lactulose 10g (less than 1.6g galactose, less than 1.2g lactose, and 0.1g or less of fructose). It also contains D&C Yellow No. 10, FD & C Yellow No. 6 and Purified Water. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-0-ß-D-galactopyranos-D-fructofuranose. It has the following structural formula:. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "51655-195-51",
"PackageDescription": "40 TABLET, COATED in 1 BOTTLE, PLASTIC (51655-195-51) ",
"NDC11Code": "51655-0195-51",
"ProductNDC": "51655-195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol Tablets",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209312",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221216",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol tablets, USP 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 tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-.(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with \"G\" above the score line on one side and \"500\" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with \"G\" on one side and \"750\" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide."
},
{
"NDCCode": "83119-126-30",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (83119-126-30) / 30 mL in 1 BOTTLE",
"NDC11Code": "83119-0126-30",
"ProductNDC": "83119-126",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meo Uv Clear Sunscreen",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221128",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020.10",
"LabelerName": "Sage Pharmaceuticals Inc",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "11.3",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221128",
"SamplePackage": "N",
"IndicationAndUsage": "UVA / UVB / HEV protection."
},
{
"NDCCode": "83119-242-50",
"PackageDescription": "1 JAR in 1 BOX (83119-242-50) / 13 g in 1 JAR",
"NDC11Code": "83119-0242-50",
"ProductNDC": "83119-242",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sun Cushion Baby And Kid",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251204",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Sage Pharmaceuticals Inc",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "9.72; 9.5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251204",
"SamplePackage": "N"
},
{
"NDCCode": "83119-243-50",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (83119-243-50) / 50 mL in 1 BOTTLE",
"NDC11Code": "83119-0243-50",
"ProductNDC": "83119-243",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unid Physical Sun",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221128",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020.10",
"LabelerName": "Sage Pharmaceuticals Inc",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "11.3",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221128",
"SamplePackage": "N",
"IndicationAndUsage": "HVA / UVB protection : 1 Tear-free formula, 2 Paraben free, 3 Hypoallergenic, 4 Fragrance free."
},
{
"NDCCode": "83119-245-50",
"PackageDescription": "1 BOTTLE in 1 BOX (83119-245-50) / 30 g in 1 BOTTLE",
"NDC11Code": "83119-0245-50",
"ProductNDC": "83119-245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Unid Sea Fennel Tinted Sun Protector",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251218",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Sage Pharmaceuticals Inc",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "8.28",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251218",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "0132-0507-24",
"PackageDescription": "24 TABLET, CHEWABLE in 1 JAR (0132-0507-24) ",
"NDC11Code": "00132-0507-24",
"ProductNDC": "0132-0507",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Phazyme",
"NonProprietaryName": "Simethicone And Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160301",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M002",
"LabelerName": "C.B. Fleet Company, Inc.",
"SubstanceName": "CALCIUM CARBONATE; DIMETHICONE",
"StrengthNumber": "750; 250",
"StrengthUnit": "mg/241; mg/241",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160301",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "for the relief of: 1 Pressure and bloating commonly referred to as gas, 2 Acid indigestion, 3 Heartburn, 4 Sour stomach, 5 Upset stomach associated with these symptoms."
},
{
"NDCCode": "0132-0522-24",
"PackageDescription": "24 CLOTH in 1 PACKAGE (0132-0522-24) ",
"NDC11Code": "00132-0522-24",
"ProductNDC": "0132-0522",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fleet",
"NonProprietaryName": "Glycerin And Phenylephrine Hci And Pramoxine Hci",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160301",
"EndMarketingDate": "20180731",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "C.B. Fleet Company, Inc.",
"SubstanceName": "GLYCERIN; PRAMOXINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "20; 1; .25",
"StrengthUnit": "g/241; g/241; g/241",
"Status": "Deprecated",
"LastUpdate": "2018-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160301",
"EndMarketingDatePackage": "20180731",
"SamplePackage": "N"
},
{
"NDCCode": "0276-0509-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0276-0509-30) ",
"NDC11Code": "00276-0509-30",
"ProductNDC": "0276-0509",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mefenamic Acid",
"NonProprietaryName": "Mefenamic Acid",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091608",
"LabelerName": "Misemer Pharmaceuticals, Inc",
"SubstanceName": "MEFENAMIC ACID",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS). Mefenamic acid is indicated: 1 For relief of mild to moderate pain in patients ≥14 years of age, when therapy will not exceed one week (7 days). , 2 For treatment of primary dysmenorrhea.",
"Description": "Mefenamic acid is a member of the fenamate group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each green-banded, yellow capsule contains 250 mg of mefenamic acid for oral administration. Mefenamic acid is a white to greyish-white, odorless, microcrystalline powder with a melting point of 230°-231°C and water solubility of 0.004% at pH 7.1. The chemical name is N-2,3-xylylanthranilic acid. The molecular weight is 241.29. Its molecular formula is C 15H 15NO 2 and the structural formula of mefenamic acid is:. Each capsule also contains lactose monohydrate. The capsule shell and band contain dimethicone, D&C yellow No. 10, FD&C blue No. 1 aluminum lake, FD&C yellow No. 6, gelatin, propylene glycol, shellac, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "0276-0510-10",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (0276-0510-10) ",
"NDC11Code": "00276-0510-10",
"ProductNDC": "0276-0510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200958",
"LabelerName": "Misemer Pharmaceutical",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220913",
"SamplePackage": "N",
"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,1000 mg, a carbamate derivative of gualfenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is a 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. Methocarbamol tablet, 1000 mg is available as an orange, film coated, oblong-shaped tablet containing 1000 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, lactose monohydrate, polyethylene glycol, triacetin, titanium dioxide."
},
{
"NDCCode": "0404-9992-10",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9992-10) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00404-9992-10",
"ProductNDC": "0404-9992",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20230406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206128",
"LabelerName": "Henry Schein, Inc",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "1000",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230406",
"SamplePackage": "N",
"IndicationAndUsage": "The injectable form of 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 this drug 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 injection, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free, clear colorless solution, free from visible particles intended for intramuscular or intravenous administration. Each mL contains: Methocarbamol, USP 100 mg, Polyethylene Glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the molecular formula of C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol, USP is a white bulky powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol injection, USP has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE."
},
{
"NDCCode": "0440-1740-40",
"PackageDescription": "40 TABLET in 1 BOTTLE, PLASTIC (0440-1740-40)",
"NDC11Code": "00440-1740-40",
"ProductNDC": "0440-1740",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030129",
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"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
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"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."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
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"Description": "Methocarbamol Tablets, USP, 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. Methocarbamol tablet USP, 500 mg is available as a white, round, scored, film-coated tablet, debossed “ASC” over the score on one side and “500” on the other side. Methocarbamol tablet USP, 750 mg is available as white, capsule-shaped, film-coated tablet, debossed “ASC” on one side and “750” on the other side. Each tablet for oral administration contains 500 mg or 750 mg methocarbamol. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, lecithin, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
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"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, 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. Methocarbamol tablet USP, 500 mg is available as a white, round, scored, film-coated tablet, debossed “ASC” over the score on one side and “500” on the other side. Methocarbamol tablet USP, 750 mg is available as white, capsule-shaped, film-coated tablet, debossed “ASC” on one side and “750” on the other side. Each tablet for oral administration contains 500 mg or 750 mg methocarbamol. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, lecithin, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide."
},
{
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"PackageDescription": "15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8506-05) ",
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"ProductNDC": "0615-8506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213967",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "METHOCARBAMOL",
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"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
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"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, 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 bulky powder, sparingly soluble in water and chloroform, soluble in alcohol only with heating and insoluble in benzene and n-hexane. Methocarbamol tablets USP, 500 mg are available as white in color, round, beveled edge, biconvex film-coated tablet containing 500 mg of methocarbamol USP for oral administration. Methocarbamol tablets USP, 750 mg are available as white in color, biconvex capsule shaped film-coated tablet containing 750 mg of methocarbamol USP for oral administration. Methocarbamol tablets USP, 500 mg and 750 mg contain the following inactive ingredients: corn starch, hypromellose, magnesium stearate, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP for 500 mg."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
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"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, 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 bulky powder, sparingly soluble in water and chloroform, soluble in alcohol only with heating and insoluble in benzene and n-hexane. Methocarbamol tablets USP, 500 mg are available as white in color, round, beveled edge, biconvex film-coated tablet containing 500 mg of methocarbamol USP for oral administration. Methocarbamol tablets USP, 750 mg are available as white in color, biconvex capsule shaped film-coated tablet containing 750 mg of methocarbamol USP for oral administration. Methocarbamol tablets USP, 500 mg and 750 mg contain the following inactive ingredients: corn starch, hypromellose, magnesium stearate, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP for 500 mg."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
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"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, 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 bulky powder, sparingly soluble in water and chloroform, soluble in alcohol only with heating and insoluble in benzene and n-hexane. Methocarbamol tablets USP, 500 mg are available as white in color, round, beveled edge, biconvex film-coated tablet containing 500 mg of methocarbamol USP for oral administration. Methocarbamol tablets USP, 750 mg are available as white in color, biconvex capsule shaped film-coated tablet containing 750 mg of methocarbamol USP for oral administration. Methocarbamol tablets USP, 500 mg and 750 mg contain the following inactive ingredients: corn starch, hypromellose, magnesium stearate, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP for 500 mg."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Robaxin",
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"LabelerName": "Hikma Pharmaceuticals USA Inc.",
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"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
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"IndicationAndUsage": "The injectable form of 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 this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "ROBAXIN (methocarbamol injection, USP) Injectable, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3‑(2‑methoxyphenoxy)‑1,2-propanediol 1‑carbamate and has the empirical formula of 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. ROBAXIN Injectable has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE."
},
{
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"ProductNDC": "0641-6103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Robaxin",
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"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
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"ApplicationNumber": "NDA011790",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
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"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
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"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "The injectable form of 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 this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "ROBAXIN (methocarbamol injection, USP) Injectable, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3‑(2‑methoxyphenoxy)‑1,2-propanediol 1‑carbamate and has the empirical formula of 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. ROBAXIN Injectable has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ApplicationNumber": "NDA011790",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "The injectable form of 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 this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "ROBAXIN (methocarbamol injection, USP) Injectable, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3‑(2‑methoxyphenoxy)‑1,2-propanediol 1‑carbamate and has the empirical formula of 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. ROBAXIN Injectable has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE."
},
{
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"LabelerName": "Hikma Pharmaceuticals USA Inc.",
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"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
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"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20261231",
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"IndicationAndUsage": "The injectable form of 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 this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "ROBAXIN (methocarbamol injection, USP) Injectable, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3‑(2‑methoxyphenoxy)‑1,2-propanediol 1‑carbamate and has the empirical formula of 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. ROBAXIN Injectable has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE."
},
{
"NDCCode": "0904-7057-61",
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"ProductNDC": "0904-7057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086988",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171215",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol tablets, USP 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 chemical name of methocarbamol is 3-(2-meth-oxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol, USP 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. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP, 500 mg and 750 mg contain the following inactive ingredients: magnesium stearate, povidone, and sodium starch glycolate."
},
{
"NDCCode": "0904-7058-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7058-61) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00904-7058-61",
"ProductNDC": "0904-7058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
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"Description": "Methocarbamol tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-meth-oxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol, USP 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. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP, 500 mg and 750 mg contain the following inactive ingredients: magnesium stearate, povidone, and sodium starch glycolate."
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"Description": "Methocarbamol Tablets, USP, 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. Methocarbamol Tablets, USP 500 mg are available as a white, round, scored, film-coated tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, povidone (k-30), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Methocarbamol Tablets, USP 750 mg are available as a white, capsule-shaped, film-coated tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, povidone (k-30), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80."
}
]
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<Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15mL contains: Lactulose 10g (less than 1.6g galactose, less than 1.2g lactose, and 0.1g or less of fructose). It also contains D&C Yellow No. 10, FD & C Yellow No. 6 and Purified Water. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-0-ß-D-galactopyranos-D-fructofuranose. It has the following structural formula:. The molecular weight is 342.30. It is freely soluble in water.</Description>
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<Description>Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-.(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with "G" above the score line on one side and "500" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and "750" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide.</Description>
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<StartMarketingDatePackage>20251218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0132-0507-24</NDCCode>
<PackageDescription>24 TABLET, CHEWABLE in 1 JAR (0132-0507-24) </PackageDescription>
<NDC11Code>00132-0507-24</NDC11Code>
<ProductNDC>0132-0507</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Phazyme</ProprietaryName>
<NonProprietaryName>Simethicone And Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160301</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M002</ApplicationNumber>
<LabelerName>C.B. Fleet Company, Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE; DIMETHICONE</SubstanceName>
<StrengthNumber>750; 250</StrengthNumber>
<StrengthUnit>mg/241; mg/241</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the relief of: 1 Pressure and bloating commonly referred to as gas, 2 Acid indigestion, 3 Heartburn, 4 Sour stomach, 5 Upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0132-0522-24</NDCCode>
<PackageDescription>24 CLOTH in 1 PACKAGE (0132-0522-24) </PackageDescription>
<NDC11Code>00132-0522-24</NDC11Code>
<ProductNDC>0132-0522</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fleet</ProprietaryName>
<NonProprietaryName>Glycerin And Phenylephrine Hci And Pramoxine Hci</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160301</StartMarketingDate>
<EndMarketingDate>20180731</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>C.B. Fleet Company, Inc.</LabelerName>
<SubstanceName>GLYCERIN; PRAMOXINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 1; .25</StrengthNumber>
<StrengthUnit>g/241; g/241; g/241</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<EndMarketingDatePackage>20180731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0276-0509-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0276-0509-30) </PackageDescription>
<NDC11Code>00276-0509-30</NDC11Code>
<ProductNDC>0276-0509</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mefenamic Acid</ProprietaryName>
<NonProprietaryName>Mefenamic Acid</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091608</ApplicationNumber>
<LabelerName>Misemer Pharmaceuticals, Inc</LabelerName>
<SubstanceName>MEFENAMIC ACID</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS). Mefenamic acid is indicated: 1 For relief of mild to moderate pain in patients ≥14 years of age, when therapy will not exceed one week (7 days). , 2 For treatment of primary dysmenorrhea.</IndicationAndUsage>
<Description>Mefenamic acid is a member of the fenamate group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each green-banded, yellow capsule contains 250 mg of mefenamic acid for oral administration. Mefenamic acid is a white to greyish-white, odorless, microcrystalline powder with a melting point of 230°-231°C and water solubility of 0.004% at pH 7.1. The chemical name is N-2,3-xylylanthranilic acid. The molecular weight is 241.29. Its molecular formula is C 15H 15NO 2 and the structural formula of mefenamic acid is:. Each capsule also contains lactose monohydrate. The capsule shell and band contain dimethicone, D&C yellow No. 10, FD&C blue No. 1 aluminum lake, FD&C yellow No. 6, gelatin, propylene glycol, shellac, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0276-0510-10</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (0276-0510-10) </PackageDescription>
<NDC11Code>00276-0510-10</NDC11Code>
<ProductNDC>0276-0510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200958</ApplicationNumber>
<LabelerName>Misemer Pharmaceutical</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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,1000 mg, a carbamate derivative of gualfenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is a 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. Methocarbamol tablet, 1000 mg is available as an orange, film coated, oblong-shaped tablet containing 1000 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, lactose monohydrate, polyethylene glycol, triacetin, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0404-9992-10</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (0404-9992-10) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00404-9992-10</NDC11Code>
<ProductNDC>0404-9992</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20230406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206128</ApplicationNumber>
<LabelerName>Henry Schein, Inc</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The injectable form of 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 this drug 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 injection, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free, clear colorless solution, free from visible particles intended for intramuscular or intravenous administration. Each mL contains: Methocarbamol, USP 100 mg, Polyethylene Glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the molecular formula of C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol, USP is a white bulky powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol injection, USP has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE.</Description>
</NDC>
<NDC>
<NDCCode>0440-1740-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE, PLASTIC (0440-1740-40)</PackageDescription>
<NDC11Code>00440-1740-40</NDC11Code>
<ProductNDC>0440-1740</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>Liberty Pharmaceuticals, 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>20181231</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>0615-8435-39</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8435-39) </PackageDescription>
<NDC11Code>00615-8435-39</NDC11Code>
<ProductNDC>0615-8435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170208</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203550</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</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>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220714</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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, 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. Methocarbamol tablet USP, 500 mg is available as a white, round, scored, film-coated tablet, debossed “ASC” over the score on one side and “500” on the other side. Methocarbamol tablet USP, 750 mg is available as white, capsule-shaped, film-coated tablet, debossed “ASC” on one side and “750” on the other side. Each tablet for oral administration contains 500 mg or 750 mg methocarbamol. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, lecithin, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0615-8436-39</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8436-39) </PackageDescription>
<NDC11Code>00615-8436-39</NDC11Code>
<ProductNDC>0615-8436</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170208</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203550</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</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>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220718</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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, 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. Methocarbamol tablet USP, 500 mg is available as a white, round, scored, film-coated tablet, debossed “ASC” over the score on one side and “500” on the other side. Methocarbamol tablet USP, 750 mg is available as white, capsule-shaped, film-coated tablet, debossed “ASC” on one side and “750” on the other side. Each tablet for oral administration contains 500 mg or 750 mg methocarbamol. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, lecithin, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0615-8506-05</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8506-05) </PackageDescription>
<NDC11Code>00615-8506-05</NDC11Code>
<ProductNDC>0615-8506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213967</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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, 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 bulky powder, sparingly soluble in water and chloroform, soluble in alcohol only with heating and insoluble in benzene and n-hexane. Methocarbamol tablets USP, 500 mg are available as white in color, round, beveled edge, biconvex film-coated tablet containing 500 mg of methocarbamol USP for oral administration. Methocarbamol tablets USP, 750 mg are available as white in color, biconvex capsule shaped film-coated tablet containing 750 mg of methocarbamol USP for oral administration. Methocarbamol tablets USP, 500 mg and 750 mg contain the following inactive ingredients: corn starch, hypromellose, magnesium stearate, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP for 500 mg.</Description>
</NDC>
<NDC>
<NDCCode>0615-8506-39</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8506-39) </PackageDescription>
<NDC11Code>00615-8506-39</NDC11Code>
<ProductNDC>0615-8506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213967</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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, 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 bulky powder, sparingly soluble in water and chloroform, soluble in alcohol only with heating and insoluble in benzene and n-hexane. Methocarbamol tablets USP, 500 mg are available as white in color, round, beveled edge, biconvex film-coated tablet containing 500 mg of methocarbamol USP for oral administration. Methocarbamol tablets USP, 750 mg are available as white in color, biconvex capsule shaped film-coated tablet containing 750 mg of methocarbamol USP for oral administration. Methocarbamol tablets USP, 500 mg and 750 mg contain the following inactive ingredients: corn starch, hypromellose, magnesium stearate, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP for 500 mg.</Description>
</NDC>
<NDC>
<NDCCode>0615-8507-39</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8507-39) </PackageDescription>
<NDC11Code>00615-8507-39</NDC11Code>
<ProductNDC>0615-8507</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213967</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<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, 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 bulky powder, sparingly soluble in water and chloroform, soluble in alcohol only with heating and insoluble in benzene and n-hexane. Methocarbamol tablets USP, 500 mg are available as white in color, round, beveled edge, biconvex film-coated tablet containing 500 mg of methocarbamol USP for oral administration. Methocarbamol tablets USP, 750 mg are available as white in color, biconvex capsule shaped film-coated tablet containing 750 mg of methocarbamol USP for oral administration. Methocarbamol tablets USP, 500 mg and 750 mg contain the following inactive ingredients: corn starch, hypromellose, magnesium stearate, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP for 500 mg.</Description>
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<IndicationAndUsage>The injectable form of 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 this drug 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>ROBAXIN (methocarbamol injection, USP) Injectable, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3‑(2‑methoxyphenoxy)‑1,2-propanediol 1‑carbamate and has the empirical formula of 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. ROBAXIN Injectable has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE.</Description>
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<IndicationAndUsage>The injectable form of 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 this drug 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>ROBAXIN (methocarbamol injection, USP) Injectable, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3‑(2‑methoxyphenoxy)‑1,2-propanediol 1‑carbamate and has the empirical formula of 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. ROBAXIN Injectable has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE.</Description>
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<IndicationAndUsage>The injectable form of 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 this drug 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>ROBAXIN (methocarbamol injection, USP) Injectable, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3‑(2‑methoxyphenoxy)‑1,2-propanediol 1‑carbamate and has the empirical formula of 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. ROBAXIN Injectable has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE.</Description>
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<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
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<IndicationAndUsage>The injectable form of 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 this drug 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>ROBAXIN (methocarbamol injection, USP) Injectable, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3‑(2‑methoxyphenoxy)‑1,2-propanediol 1‑carbamate and has the empirical formula of 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. ROBAXIN Injectable has a pH between 3.5 and 6.0. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE.</Description>
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<IndicationAndUsage>Methocarbamol tablets, USP 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 chemical name of methocarbamol is 3-(2-meth-oxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol, USP 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. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP, 500 mg and 750 mg contain the following inactive ingredients: magnesium stearate, povidone, and sodium starch glycolate.</Description>
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<IndicationAndUsage>Methocarbamol tablets, USP 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 chemical name of methocarbamol is 3-(2-meth-oxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol, USP 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. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP, 500 mg and 750 mg contain the following inactive ingredients: magnesium stearate, povidone, and sodium starch glycolate.</Description>
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<IndicationAndUsage>Methocarbamol Tablets, USP 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, 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. Methocarbamol Tablets, USP 500 mg are available as a white, round, scored, film-coated tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, povidone (k-30), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Methocarbamol Tablets, USP 750 mg are available as a white, capsule-shaped, film-coated tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, povidone (k-30), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80.</Description>
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<IndicationAndUsage>Methocarbamol Tablets, USP 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, 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. Methocarbamol Tablets, USP 500 mg are available as a white, round, scored, film-coated tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, povidone (k-30), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Methocarbamol Tablets, USP 750 mg are available as a white, capsule-shaped, film-coated tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, povidone (k-30), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80.</Description>
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